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4523.T JP Equity

Eisai Co., Ltd.Health Care · FY ends Mar 31
JPY 4,729.00
-129.00 (-2.66%)
JPY · as of 2026-08-17 · marketstack
564 registered studies · 27 active

Studies where 4523.T is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.

Of the 500 shown: 446 interventional · 52 observational · 2 expanded access · 227 with posted results

Held by 0 tracked-famous managers · government filings 180d: none disclosed

StudyPhaseStatusInterventionsConditionsEnrollmentPrimary completionReadout inUpdated
A Post Authorization Registry Study of Participants Treated With LEQEMBINCT07762092observationalIncidence and Severity of Known AEsNot yet recruitingOther: No InterventionAlzheimers Disease4002036-04-01in 3,513 d2026-08-13
A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After ChemotherapyNCT06793709observationalNumber of Participants With Adverse Drug ReactionsRecruitingOther: No InterventionBiliary Tract Cancer602032-11-20in 2,285 d2026-02-27
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor TypesNCT04300556Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab EcteribulinRandomized · Open-label · TreatmentPhase 1/2RecruitingDrug: Farletuzumab ecteribulin, Prednisone, Prednisolone, Dexamethasone, LenvatinibSolid Tumor1822030-08-08in 1,450 d2026-06-04
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)NCT07768592Part A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Binding Potential (BPND) at 14 DaysRandomized · Open-label · TreatmentPhase 1Not yet recruitingDrug: E2511, DonepezilAlzheimers Disease322030-05-06in 1,356 d2026-08-17
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's DiseaseNCT03887455Core Study: Change from Baseline in the CDR-SB at 18 MonthsRandomized · Quadruple-masked · TreatmentPhase 3Active, not recruitingDrug: Lecanemab IV, Placebo, Lecanemab SCEarly Alzheimer's Disease1,9062029-06-30in 1,046 d2026-04-07
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate AmyloidNCT04468659A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216Randomized · Quadruple-masked · TreatmentPhase 3Active, not recruitingDrug: Lecanemab, PlaceboPreclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease1,4002028-12-21in 855 d2026-06-04
A Study of E6742 in Participants With Systemic Lupus ErythematosusNCT07515014Percentage of Participants who Achieve a BICLA Response with Low Dose of OCS (Prednisone or Equivalent) at Week 24Randomized · Double-masked · TreatmentPhase 2RecruitingDrug: E6742 · Other: PlaceboSystemic Lupus Erythematosus2562028-08-05in 717 d2026-07-02
A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic SeizuresNCT06657378observationalNumber of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)RecruitingOther: No InterventionPartial-Onset Seizures, Primary Generalized Tonic-clonic Seizures1102028-06-15in 666 d2026-07-01
A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in JapanNCT05228158observationalNumber of Participants With Adverse Drug Reactions (ADRs)Active, not recruitingDrug: TazemetostatLymphoma, Follicular1452028-03-31in 590 d2026-01-02
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid PathologyNCT06043700observationalNumber of Participants With Low, Medium, and High Amyloid PathologyActive, not recruitingOther: No InterventionAlzheimer's Disease2,0002028-03-31in 590 d2026-03-05
A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With LecanemabNCT06322667observationalNumber of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)RecruitingOther: No InterventionAlzheimer's Disease5,0002027-12-31in 499 d2026-01-23
A Study of Oral E1018 in Healthy Adult ParticipantsNCT06854042Number of Participants With Dose-limiting EventsRandomized · Quadruple-masked · TreatmentPhase 1Active, not recruitingDrug: E1018, PlaceboMalaria, Healthy Participants322027-07-22in 337 d2026-08-07
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood EpilepsyNCT04015141Proportion of 50% Responders For All Seizures During the Maintenance Period of Core StudyOpen-label · TreatmentPhase 2Active, not recruitingDrug: Perampanel Oral Suspension, Perampanel TabletPediatric Epileptic Syndrome, Partial-onset Seizures1002027-04-06in 230 d2026-07-10
Study of E7386 in Participants With Selected Advanced NeoplasmsNCT03264664Number of Participants With Dose-limiting Toxicities (DLTs)Open-label · TreatmentPhase 1Active, not recruitingDrug: E7386Advanced Neoplasms602027-03-31in 224 d2026-06-08
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)NCT03833700Number of Participants with Dose-limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentPhase 1Active, not recruitingDrug: E7386Solid Neoplasms, Colorectal Neoplasms, Gastrointestinal Tumors702027-03-31in 224 d2026-02-27
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid TumorNCT04008797Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)Randomized · Open-label · TreatmentPhase 1/2Active, not recruitingDrug: E7386, Lenvatinib, Doxorubicin, PaclitaxelEndometrial Neoplasms, Neoplasms, Carcinoma, Hepatocellular, Liver Neoplasms, Colorectal Neoplasms3012027-03-31in 224 d2026-03-24
A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid TumorNCT04078295Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentPhase 1/2Active, not recruitingDrug: E7389-LF, NivolumabSolid Neoplasms1252027-03-31in 224 d2026-02-10
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With NarcolepsyNCT07493265Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2Randomized · Triple-masked · TreatmentPhase 2RecruitingDrug: E2086, PlaceboNarcolepsy642027-02-14in 179 d2026-05-14
A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's DiseaseNCT07723950observationalPositive Predictive Value (PPV) of algorithms to identify intracerebral hemorrhage >1 cm in diameterNot yet recruitingOther: No interventionAlzheimer's Disease6002026-12-31in 134 d2026-07-23
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's DiseaseNCT06602258Change From Baseline in CSF MTBR-tau-243 at 6 MonthsRandomized · Quadruple-masked · TreatmentPhase 2Active, not recruitingDrug: E2814, Lecanemab, PlaceboAlzheimer's Disease1052026-12-03in 106 d2026-02-11
Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy ParticipantsNCT04271488Cmax: Maximum Observed Plasma Concentration of TasurgratinibNon-randomized · Open-label · TreatmentPhase 1RecruitingDrug: Tasurgratinib, TasurgratinibHepatic Impairment182026-11-30in 103 d2026-01-23
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy ParticipantsNCT07766369Part A, area under concentration versus time curve from zero time (predose) to time of last quantifiable concentration AUC(0-t) of E2086 and its Metabolite M1Non-randomized · Open-label · TreatmentPhase 1Not yet recruitingDrug: E2086Healthy Volunteers932026-11-12in 85 d2026-08-14
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male ParticipantsNCT07308236Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled DoseOpen-label · Basic sciencePhase 1RecruitingDrug: E2086Healthy Volunteers102026-02-232026-03-05
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control PopulationNCT06744673observationalPercentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort CActive, not recruitingOther: No InterventionSleep Initiation and Maintenance Disorders, Pregnancy8612025-12-302025-06-19
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast CancerNCT04288089results2024-03-22Maximum Tolerated Dose (MTD) of H3B-6545 and PalbociclibOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1Active, not recruitingDrug: Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms312022-09-16actual2026-02-27
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell CarcinomaNCT02811861results2021-09-24Progression-free Survival (PFS) by Independent Imaging Review (IIR)Randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3Active, not recruitingDrug: Lenvatinib, Everolimus, Pembrolizumab, SunitinibRenal Cell Carcinoma1,0692020-08-28actual2026-02-23
Study of E7389 Liposomal Formulation in Participants With Solid TumorNCT03207672Maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF)Non-randomized · Open-label · TreatmentPhase 1Active, not recruitingDrug: E7389-LFSolid Tumor1402018-07-19actual2026-03-03
A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast CancerNCT04572295Part 1: Recommended Dose (RD) of E7090 in Combination With Other Anticancer AgentsNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7090, Fulvestrant, ExemestaneBreast Neoplasms512026-06-18actual2026-07-17
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast CancerNCT06188559Part 1, Dose Optimization: Number of Participants With Adverse Events (AEs)Randomized · Open-label · TreatmentPhase 2CompletedDrug: BB-1701Breast Cancer562026-03-18actual2026-05-22
A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene FusionNCT04238715ORROpen-label · TreatmentPhase 2CompletedDrug: E7090Cholangiocarcinoma632025-11-03actual2026-03-02
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast CancerNCT04568902Number of Participants With Dose-limiting Toxicities (DLTs)Randomized · Open-label · TreatmentPhase 1CompletedDrug: H3B-6545, AntihistamineBreast Neoplasms332025-10-01actual2025-10-23
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1NCT06462404Mean Sleep Latency (MSL) as Assessed by the 4 Maintenance of Wakefulness Tests (MWTs) for E2086 Versus Placebo at Day 1Randomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: E2086, E2086 Placebo, Active Comparator, Active Comparator PlaceboNarcolepsy Type 1 (NT1)222025-03-17actual2025-06-04
A Study of E7130 in Participants With Solid TumorsNCT03444701Part 1: Number of participants assigned to the every 2 weeks regimen with dose-limiting toxicities (DLTs)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7130, E7130Solid Tumors622024-12-27actual2025-03-06
A Study of E2086 in Healthy Adult ParticipantsNCT06481488Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Basic sciencePhase 1CompletedDrug: E2086, PlaceboHealthy Volunteers322024-12-13actual2025-01-16
A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's DiseaseNCT01767311results2026-03-04Core Study Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at Month 12Randomized · Triple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Lecanemab 2.5 mg/kg, Lecanemab 5.0 mg/kg, Lecanemab 10 mg/kg, Lecanemab 5.0 mg/kg, Lecanemab 10 mg/kg, Placebo, Lecanemab 10 mg/kgAlzheimer's Disease8562024-12-10actual2026-03-04
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid TumorsNCT05091346results2025-10-24Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs)Randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: E7386, Pembrolizumab, LenvatinibMelanoma, Carcinoma, Hepatocellular, Colorectal Neoplasms892024-10-15actual2025-10-24
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet SyndromeNCT04572243results2025-10-08Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3Terminatedsponsor's stated reason: The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.Drug: Placebo, LorcaserinEpilepsies, Myoclonic222024-08-15actual2025-10-08
A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's DiseaseNCT04971733results2025-06-10Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: E2814Alzheimer Disease82024-05-24actual2025-06-10
A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia DisorderNCT05594589results2025-07-03Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to PlaceboRandomized · Triple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Lemborexant · Other: PBOSleep Initiation and Maintenance Disorders652024-04-26actual2025-07-03
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of E2025 in Healthy ParticipantsNCT05726851Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Basic sciencePhase 1CompletedDrug: E2025, PlaceboHealthy Volunteers322024-01-30actual2024-03-25
A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly ParticipantsNCT05745207Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · OtherPhase 1CompletedDrug: E2086, PlaceboHealthy Volunteers532024-01-18actual2024-10-02
Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib TrialsNCT03477175results2025-01-07Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs)Non-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: E7080, Comparator Drug, Comparator Drug: SorafenibSolid Tumors402023-12-21actual2025-01-07
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular CarcinomaNCT04763408observationalNumber of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With LenvatinibCompletedDrug: Lenvatinib, SorafenibCarcinoma, Hepatocellular3352023-12-13actual2024-07-18
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast CancerNCT03250676results2025-02-25Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: H3B-6545Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast, Breast Cancer Female, Breast Adenocarcinoma, Estrogen Receptor Positive Tumor, ER Positive1512023-10-26actual2025-02-25
A Study Based on the French National Health Insurance Database in Participants With Psychotic DisordersNCT05633108observationalTime from Discharge from a Psychiatric Hospitalization to the Next Psychiatric RehospitalizationCompletedOther: No InterventionPsychotic Disorders579,7282023-09-30actual2023-11-18
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus ParticipantsNCT05278663Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · TreatmentPhase 1/2CompletedDrug: E6742 · Other: PlaceboLupus Erythematosus, Systemic262023-09-04actual2023-09-29
A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male ParticipantsNCT05607537Part 1, %F: Percent Absolute Oral Bioavailability for (14C)E7386 and E7386Non-randomized · Open-label · Basic sciencePhase 1CompletedDrug: E7386 Tablet, (14C)E7386 Capsule, (14C)E7386Healthy Volunteers152023-08-31actual2023-09-21
A Study to Assess the Safety and Tolerability of E8001 in Healthy Male ParticipantsNCT04609852Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Single-masked · OtherPhase 1CompletedDrug: E8001, PlaceboHealthy Volunteers362023-08-18actual2023-09-25
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With GoutNCT05007392results2025-07-30Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)Randomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: Dotinurad, Febuxostat · Other: Dotinurad Matched Placebo, Febuxostat Matched PlaceboGout4512023-06-14actual2025-07-30
A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets Compared to an E7386 Immediate Release (IR) Tablet in Healthy Adult ParticipantsNCT04840927Cmax: Maximum Observed Plasma Concentration for E7386Randomized · Open-label · OtherPhase 1Withdrawnsponsor's stated reason: Delay in availability of IMPDrug: E7386Healthy Volunteers02023-05-17actual2023-11-24
A Study of Lemborexant in Chinese Participants With Insomnia DisorderNCT04549168results2024-12-20Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to PlaceboRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: Lemborexant, PlaceboSleep Initiation and Maintenance Disorders1942023-03-17actual2024-12-20
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)NCT05137847observationalPercentage of Participants with ADRCompletedDrug: RemitoroLymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous1182023-03-17actual2023-12-12
A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy ParticipantsNCT04231513SAD, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · OtherPhase 1CompletedDrug: E2814, E2814-matched placeboHealthy Volunteers722023-03-09actual2023-04-06
A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized EpilepsyNCT04252846observationalRetention Rate at Month 12CompletedDrug: PerampanelIdiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures1912023-01-12actual2023-02-09
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy ParticipantsNCT05533801AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for LecanemabRandomized · Open-label · Basic sciencePhase 1CompletedDrug: Lecanemab, LecanemabHealthy Volunteers1602023-01-06actual2023-01-18
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular CarcinomaNCT03418922results2024-06-20Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: Lenvatinib, NivolumabCarcinoma, Hepatocellular302022-12-28actual2024-06-20
A Single and Multiple Dose Study of Dotinurad in Chinese Healthy ParticipantsNCT05278676Single-dose Part, Cmax: Maximum Observed Concentration for DotinuradNon-randomized · Open-label · Basic sciencePhase 1CompletedDrug: DotinuradHealthy Volunteers262022-12-13actual2023-09-14
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut SyndromeNCT02175173observationalInvestigations on adverse events and adverse drug reactionsCompletedDrug: RufinamideLennox-Gastaut Syndrome7072022-11-02actual2023-02-21
A Study of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin) in Participants With Solid TumorsNCT03386942Part 1: Number of participants with dose-limiting toxicities (DLTs)Open-label · TreatmentPhase 1CompletedDrug: Farletuzumab EcteribulinSolid Tumors822022-10-26actual2022-11-28
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)NCT04724109observationalNumber of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)CompletedDrug: EqufinaParkinson Disease1,0882022-10-13actual2022-12-16
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System TumorsNCT03245151results2023-08-30Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With EverolimusNon-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: Lenvatinib, EverolimusRecurrent and Refractory Solid Tumors642022-09-30actual2023-08-30
A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy, INPUT-102NCT04109092Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentPhase 1Withdrawnsponsor's stated reason: There was no enrolment of participants.Unscheduled Clinical Study Closure - Eisai Network Company Decision, November 12, 2020.Drug: E7766Urinary Bladder Neoplasms02022-09-292020-12-14
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With EpilepsyNCT02914314results2023-09-15Dose Normalized Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED ParticipantsOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: perampanelEpilepsy262022-08-23actual2024-03-15
A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly ParticipantsNCT05147337Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Double-masked · OtherPhase 1CompletedDrug: E2511, PlaceboHealthy Volunteers472022-08-18actual2022-09-09
Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101NCT04144140results2024-03-07Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1Terminatedsponsor's stated reason: The study was terminated earlier due to a business decision; which was unrelated to safety. In addition, there was no clinical activity data that informed the decision.Drug: E7766Lymphoma, Advanced Solid Tumors242022-07-26actual2024-03-07
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory OsteosarcomaNCT04154189results2023-08-07Progression-free Survival (PFS) by Independent Imaging Review (IIR) AssessmentRandomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Lenvatinib, Ifosfamide, Etoposide, LenvatinibOsteosarcoma812022-06-22actual2024-07-22
A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.NCT04573556observationalNumber of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)CompletedDrug: LemborexantSleep Initiation and Maintenance Disorders5502022-03-17actual2022-04-05
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])NCT03517449results2021-11-17Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) ParticipantsRandomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: Pembrolizumab, Lenvatinib, Paclitaxel, DoxorubicinEndometrial Neoplasms8272022-03-01actual2026-03-19
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary DiseaseNCT04647383results2023-10-10OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2Randomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: Placebo, Lemborexant 10 mg, Placebo, Lemborexant 10 mgSleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders632022-02-10actual2023-10-10
A Study of Overall Survival in Participants With Unresectable Hepatocellular CarcinomaNCT04008082observationalOverall Survival (OS)CompletedDrug: LenvatinibCarcinoma, Hepatocellular, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms4122022-01-28actual2022-03-08
Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene MutationNCT03456726results2022-12-16Objective Response Rate (ORR) Based on Independent Reviewer AssessmentNon-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: TazemetostatRelapsed or Refractory B-cell Non-Hodgkin's Lymphoma202021-12-17actual2022-12-16
A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid CopathologyNCT04764669results2022-09-26Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9Non-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: E2027Lewy Body Disease, Parkinson Disease342021-12-08actual2022-09-26
A Study of Subcutaneous Lecanemab in Healthy ParticipantsNCT05045716AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for LecanemabRandomized · Open-label · Basic sciencePhase 1CompletedDrug: Lecanemab, LecanemabHealthy Volunteers602021-12-07actual2022-01-19
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell LymphomaNCT01871727results2024-11-13Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: E7777 9 mcg/kgPersistent or Recurrent Cutaneous T-Cell Lymphoma1122021-12-06actual2024-11-13
A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced DiseaseNCT02915783results2020-07-13Objective Response Rate (ORR)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: lenvatinib, everolimusNon Clear Cell Renal Cell Carcinoma (nccRCC)412021-11-02actual2023-01-17
Phase 1 Study of E7090 in Subjects With Solid TumorNCT02275910results2025-12-16Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: E7090Tumors402021-09-03actual2025-12-16
A Study to Evaluate Lemborexant in Milk of Healthy Lactating WomenNCT04890561Ae: Cumulative Total (Unchanged) Amount of Lemborexant Excreted in Breast Milk Over the Entire CollectionOpen-label · TreatmentPhase 1CompletedDrug: LemborexantHealthy Volunteers82021-08-12actual2021-09-05
A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy ParticipantsNCT04676685Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Triple-masked · OtherPhase 1CompletedDrug: E2730, E2730-matched placeboHealthy Volunteers322021-06-23actual2021-08-26
A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult ParticipantsNCT04683185Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · OtherPhase 1CompletedDrug: E6742, PlaceboHealthy Volunteers242021-06-21actual2021-07-20
Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeNCT02834793results2022-03-09Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline)Randomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3Terminatedsponsor's stated reason: Sponsor's decisionDrug: Placebo, PerampanelLennox-Gastaut Syndrome (LGS)1012021-05-26actual2022-03-09
A Study to Assess the Safety and Tolerability of E2511 in Healthy ParticipantsNCT04547361Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · OtherPhase 1CompletedDrug: E2511, E2511 Matched PlaceboHealthy Volunteers452021-05-26actual2021-07-12
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid TumorsNCT03245450results2022-06-28Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan HydrochlorideOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: Eribulin mesilate, Irinotecan hydrochlorideRefractory or Recurrent Solid Tumors, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Ewing Sarcoma402021-05-17actual2022-06-28
Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic SeizuresNCT03288129results2022-05-16Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of TreatmentOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 4CompletedDrug: PerampanelPartial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures542021-04-27actual2022-05-16
A Study to Assess the Effect of Food Intake and Drug-drug Interactions of E7090 When Co-administered With Rabeprazole or Rifampin in Healthy ParticipantsNCT04565574Cmax: Maximum Observed Plasma Concentration of E7090Randomized · Open-label · TreatmentPhase 1CompletedDrug: E7090, Rabeprazole 20 mg, Rifampin 600 mgHealthy Participants422021-03-31actual2021-11-01
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic SeizuresNCT03059381observationalNumber of participants with any serious adverse eventCompletedDrug: FycompaPartial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures5192021-03-21actual2022-08-05
A Single and Multiple Dose Study of Lemborexant in Healthy Chinese ParticipantsNCT04555733Cmax: Maximum Observed Plasma Concentration for Lemborexant and Its Metabolites (M4, M9, and M10) Following Single Dose in All CohortsNon-randomized · Open-label · OtherPhase 1CompletedDrug: LemborexantHealthy Volunteer262021-01-13actual2021-07-19
Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)NCT03441360results2022-01-28Percentage of Participants With Objective ResponseNon-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Eribulin mesylateRelapsed/Refractory Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma, Ewing Sarcoma232021-01-07actual2022-10-05
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male ParticipantsNCT04493255feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in UrineOpen-label · OtherPhase 1CompletedDrug: [14C]E7090Healthy Volunteers82020-10-21actual2021-02-04
A Study to Determine the Signs and Symptoms That Impact Daily Life of Participants With Irregular Sleep-Wake Rhythm DisorderNCT04300569observationalDevelopment of Scale for the Assessment of the Signs and Symptoms of Irregular Sleep-wake Rhythm Disorder (ISWRD) Based on Interview DataCompletedOther: Non-interventionalIrregular Sleep Wake Rhythm Disorder372020-09-07actual2020-10-27
A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid TumorsNCT02501096results2023-07-20Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of LenvatinibOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: Lenvatinib, PembrolizumabTumors3572020-08-18actual2023-07-20
Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Participants With Selected Solid TumorsNCT03006887results2021-05-20Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: lenvatinib, pembrolizumabSolid Tumors62020-04-15actual2021-05-20
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy BodiesNCT03467152results2022-08-01Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of TreatmentRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Irsenontrine, PlaceboDementia With Lewy Bodies3262020-04-15actual2022-08-01
Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 YearsNCT03338296results2021-07-19Change in Body Mass Index (BMI) From Baseline up to Week 52Randomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 4Terminatedsponsor's stated reason: Study was terminated as Eisai agreed to voluntarily withdraw Belviq XR from US market.Drug: lorcaserin hydrochloride XR, PlaceboObesity2782020-04-03actual2021-07-19
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of InsomniaNCT04009577results2021-04-12Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core StudyRandomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: LEM 5 mg, LEM 10 mgInsomnia532020-03-17actual2021-04-12
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male SubjectsNCT03402178Part A: Mean value of the maximum observed concentration (Cmax) of E2082 under a fasted state for the single ascending dose (SAD) Cohorts 1-10Randomized · Double-masked · TreatmentPhase 1Terminatedsponsor's stated reason: Safety ReviewDrug: E2082, PlaceboHealthy Participants1182020-02-20actual2021-06-30
A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular CarcinomaNCT03663114observationalNumber of Participants With Hepatic Encephalopathy Risk FactorsCompletedDrug: LenvatinibCarcinoma, Hepatocellular7132020-02-20actual2021-01-22
Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell CarcinomaNCT03173560results2021-03-05Objective Response Rate at Week 24 (ORR24W)Randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: lenvatinib, everolimusRenal Cell Carcinoma3432020-02-14actual2025-04-01
Clinical Trial of Ultra-high Dose Methylcobalamin for ALSNCT03548311Treatment Phase: ALSFRS-RRandomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: methylcobalamin, saline solutionAmyotrophic Lateral Sclerosis1302020-02-14actual2025-03-26
A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's DiseaseNCT02956486results2021-02-03Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3Terminatedsponsor's stated reason: Due to an unfavorable risk-benefit ratio including no evidence of potential efficacy, and the adverse event profile of E2609 being worse than placebo.Drug: Elenbecestat, PlaceboAlzheimer's Disease2,2122020-01-15actual2021-02-03
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's DiseaseNCT02322021results2021-03-05Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Randomized · Triple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2Terminatedsponsor's stated reason: This study was terminated early by the sponsor on the recommendation of an independent data safety monitoring board following review of unblinded data from the Phase 3 studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280).Drug: E2609, PlaceboAlzheimer Disease, Dementia, Alzheimer Type702019-12-20actual2021-03-05
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety ProfileNCT02702388results2021-01-11Objective Response Rate (ORR) as of Week 24 (ORR24wk)Randomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Lenvatinib, Lenvatinib matching placeboThyroid Cancer2412019-12-12actual2021-11-24
A Study of Intravenous Perampanel in Japanese Participants With EpilepsyNCT03754582results2021-01-05Number of Participants With Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Perampanel, PerampanelEpilepsy, Seizures212019-12-10actual2021-01-05
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular CarcinomaNCT03006926results2020-12-31DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: lenvatinib, pembrolizumab (200 mg)Hepatocellular Carcinoma1042019-10-31actual2023-12-13
A Food-Effect Study of E7386 in Healthy ParticipantsNCT03996226Cmax: Maximum Observed Plasma Concentration for E7386Randomized · Open-label · OtherPhase 1CompletedDrug: E7386Food Effect in Healthy Participants172019-10-29actual2019-11-14
A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male ParticipantsNCT04023877Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue)Open-label · TreatmentPhase 1CompletedDrug: E2027Dementias With Lewy Bodies82019-10-11actual2019-12-03
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic SeizuresNCT03059329observationalNumber of participants with any serious adverse eventCompletedDrug: FycompaPartial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures3,8092019-09-13actual2022-03-02
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)NCT02753595results2020-07-13Phase 1b: Recommended Phase 2 Dose (RP2D) of Eribulin Mesylate in Combination With PEGPH20Randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2Terminatedsponsor's stated reason: evolving standard of care and difficulties of enrolling participantsDrug: Eribulin mesylate, Eribulin mesylate, Eribulin mesylate · Other: Biologic: PEGylated recombinant human hyaluronidase (PEGPH20), Biologic: PEGylated recombinant human hyaluronidaseMetastatic Breast Cancer252019-08-16actual2020-07-13
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)NCT02513472results2020-08-14Objective Response Rate (ORR)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: Eribulin Mesylate, PembrolizumabBreast Neoplasm2582019-07-31actual2022-05-05
A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in ChinaNCT02966093Progression-free survival (PFS)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Lenvatinib, PlaceboDifferentiated Thyroid Cancer (DTC)1512019-07-31actual2022-01-26
Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With OsteosarcomaNCT02432274results2020-09-17Cohort 1: Recommended Dose (RD) of LenvatinibNon-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedDrug: Lenvatinib, Lenvatinib, Lenvatinib, Lenvatinib, Lenvatinib, Ifosfamide, Etoposide, Ifosfamide, EtoposideTumors, Solid Malignant Tumors, Osteosarcoma, Differentiated Thyroid Cancer (DTC)1172019-07-18actual2023-07-11
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition and Safety in Patients With Cervical DystoniaNCT02175693observationalOverall assessments of the improvement in the seriousness of seizuresCompletedCervical Dystonia1,6472019-06-30actual2020-01-09
A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast CancerNCT03583944Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · TreatmentPhase 4CompletedDrug: Eribulin MesylateBreast Neoplasms2002019-06-28actual2019-11-27
A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy ParticipantsNCT03885882Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IRRandomized · Open-label · TreatmentPhase 1CompletedDrug: E0302 SR1, E0302 SR3, E0302 SR2, E0302 IRHealthy Subjects242019-06-26actual2019-12-24
A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive EpilepsyNCT03686033results2020-09-28Mean Change From Baseline in the Photoparoxysmal Response (PPR) Range in the Most Sensitive Eye Condition at 8 Hours Postdose on Day 1 of Each Treatment PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2Terminatedsponsor's stated reason: Safety ReviewDrug: Placebo, E2082Photosensitive Epilepsy82019-06-18actual2020-09-28
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian CancerNCT02289950results2021-09-02Progression Free Survival (PFS)Randomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: Farletuzumab, PlaceboPlatinum-Sensitive Ovarian Cancer in First Relapse3322019-05-31actual2021-09-02
A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal SeizuresNCT04257604observationalPercentage Change From Baseline in all Seizures Frequency at Month 6CompletedDrug: PerampanelPartial Seizures2432019-04-30actual2020-02-06
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell LymphomaNCT02676778results2021-07-15Objective Response Rate (ORR)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: E7777Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma452019-04-26actual2021-07-15
Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With EpilepsyNCT03208660observationalPercentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)CompletedDrug: FycompaEpilepsy2,0002019-03-15actual2019-04-11
Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)NCT03201900results2020-02-25Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg PerampanelOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: E2007Partial Onset Seizures912019-02-28actual2021-08-05
A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive EpilepsyNCT03603639results2022-05-04Mean Change From Baseline in the Standard Photosensitivity Response (SPR) in the Most Sensitive Eye Condition at 8 Hours Post-dose on Day 1 of Each Treatment PeriodRandomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2Terminatedsponsor's stated reason: The study was stopped due to efficacy reasons.Drug: Placebo, E2730Photosensitive Epilepsy62019-02-14actual2022-05-04
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic SeizuresNCT02849626results2020-04-06Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants - Core Phase and Extension Phase A of This StudyOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: PerampanelPartial-Onset or Primary Generalized Tonic-Clonic Seizures1802019-02-05actual2022-10-28
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)NCT02952820results2020-01-21Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6Randomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: lemborexant, PlaceboInsomnia Disorder9712019-01-08actual2020-02-06
Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)NCT03433703results2019-12-06Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol and Statistical Analysis PlanPhase 2Terminatedsponsor's stated reason: Study recruitment was stopped due to difficulty in enrolling the targeted number of participants.Drug: LenvatinibCarcinoma, Hepatocellular82019-01-07actual2019-12-06
Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid TumorNCT03009292Area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ])Open-label · TreatmentPhase 1CompletedDrug: lenvatinibSolid Tumor122018-12-24actual2021-09-28
A Study on Safety and Efficacy in Patients With Soft Tissue SarcomasNCT03058406observationalNumber of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)CompletedDrug: Eribulin mesylateSarcoma, Soft Tissue2562018-11-04actual2020-04-06
A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)NCT02657369results2019-10-15Objective Response Rate (ORR)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2Terminatedsponsor's stated reason: Overall response rate was 3% (only 1 out of 33 participants had confirmed PR).Drug: Lenvatinib 24 mgThyroid Carcinoma, Anaplastic342018-09-26actual2019-10-15
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy ParticipantsNCT03451890Mean maximum observed concentration (Cmax) for E2730 and the N-acetyl metabolite (M1) in plasmaRandomized · Triple-masked · TreatmentPhase 1CompletedDrug: E2730, PlaceboHealthy Participants322018-09-26actual2019-03-04
Study of Lemborexant-Alcohol Interaction in Healthy SubjectsNCT03483636Change from baseline in body sway, as assessed by an ataxia meter measuring directional trunk movements, for lemborexant plus alcohol compared to lemborexant aloneRandomized · Quadruple-masked · Basic sciencePhase 1CompletedDrug: Lemborexant, Alcohol, PlaceboHealthy Subjects242018-09-12actual2018-10-17
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy ParticipantsNCT03627936Maximum Observed Plasma Concentration (Cmax) of LorcaserinRandomized · Open-label · OtherPhase 1CompletedDrug: Lorcaserin manufactured at Zofingen, Lorcaserin manufactured at KawashimaHealthy Participants402018-09-02actual2018-10-17
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal ImpairmentNCT03443063results2020-01-18Maximum Observed Plasma Concentration (Cmax) of LemborexantNon-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: LemborexantRenal Impairment162018-08-24actual2020-03-12
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep ApneaNCT03471871results2020-01-18HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of TreatmentRandomized · Double-masked · OtherStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: Placebo, Lemborexant 10 mg, Lemborexant 25 mg, Placebo, Lemborexant 10 mgObstructive Sleep Apnea, Healthy Subjects1462018-08-03actual2020-02-17
Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease DementiaNCT03001557results2020-01-14Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of TreatmentRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis Plan: Core Phase · Statistical Analysis Plan: Extension PhasePhase 2CompletedDrug: Lemborexant 2.5 mg, Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant 15 mg, Lemborexant-matched placeboIrregular Sleep-Wake Rhythm Disorder632018-07-26actual2021-05-17
A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular DiseaseNCT02660983results2019-10-04Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24Randomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 4CompletedDrug: Donepezil hydrochloride, Donepezil matching placebo, Donepezil hydrochlorideDementia Associated With Cerebrovascular Disease3022018-07-13actual2020-01-10
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative UsersNCT03158025Mean peak Maximum Effect (Emax) score for Drug Liking on a Visual Analog Scale (VAS)Randomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets, Placebo lemborexant, Placebo zolpidem, Placebo suvorexantInsomnia Disorders392018-07-04actual2020-06-29
Pharmacokinetic Study of Perampanel in Chinese Healthy SubjectsNCT03424564Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanelNon-randomized · Open-label · Basic sciencePhase 1CompletedDrug: PerampanelHealthy Subjects442018-05-25actual2018-08-28
A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to BiologicsNCT02960490results2021-08-23Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI)Randomized · Triple-masked · TreatmentStudy Protocol · Statistical Analysis Plan: Core and Entire Treatment Phase · Statistical Analysis Plan: Extension PhasePhase 2CompletedDrug: E6011, PlaceboRheumatoid Arthritis662018-05-16actual2021-08-23
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk FactorsNCT02019264results2019-07-16Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim AnalysisRandomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 4CompletedDrug: Lorcaserin hydrochloride, PlaceboCardiovascular Disease, High Cardiovascular Risk, Obesity, Overweight, Type 2 Diabetes14,6732018-05-14actual2019-07-16
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy SubjectsNCT03440424results2020-01-18Cmax: Maximum Plasma Concentration of LemborexantNon-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: LemborexantHepatic Impairment242018-04-23actual2020-03-20
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy SubjectsNCT03451110Part 1 (Lemborexant plus Loestrin): Mean maximum observed concentration (Cmax) of lemborexant and metabolitesNon-randomized · Open-label · Basic sciencePhase 1CompletedDrug: lemborexant, Loestrin, famotidine, fluconazoleHealthy Subjects502018-03-23actual2018-09-06
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese SubjectsNCT03399734Maximum observed concentration (Cmax)Randomized · Open-label · Basic sciencePhase 1CompletedDrug: Perampanel, PerampanelHealthy Participants242018-03-09actual2018-10-29
A Dose Response Study of E6011 in Participants With Rheumatoid Arthritis Inadequately Responding to MethotrexateNCT02960438results2021-06-21Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) Response at Week 12 Based on Non-responder Imputation (NRI)Randomized · Triple-masked · TreatmentStudy Protocol · Statistical Analysis Plan: Treatment Phase · Statistical Analysis Plan: Extension PhasePhase 2CompletedDrug: E6011, PlaceboRheumatoid Arthritis2732018-02-28actual2021-06-21
Study of E7046 in Subjects With Selected Advanced MalignanciesNCT02540291results2020-02-17Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1Terminatedsponsor's stated reason: Terminated due to, licensing agreement granting exclusive rights of research, development, manufacture and marketing of Eisai's E7046 to Adlai Nortye Biopharma.Drug: E7046Tumors312018-02-27actual2020-02-17
Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy SubjectsNCT03376997Mean maximum observed concentration (Cmax) postdose of perampanelRandomized · Open-label · Basic sciencePhase 1CompletedDrug: Perampanel, PerampanelHealthy Participants482018-02-16actual2018-09-07
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 YearsNCT02033902observationalNumber of Treatment Emergent Adverse Events (TEAEs) of interestCompletedDrug: PerampanelEpilepsy5002018-01-31actual2018-09-07
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)NCT02783729results2020-02-11Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30Randomized · Double-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: Lemborexant, Lemborexant, Lemborexant-matched placebo, Zolpidem tartrate, Zolpidem-matched placeboInsomnia1,0062018-01-30actual2024-11-12
A Study to Evaluate the Food-Effect of H3B-6527NCT03424577Mean area under the plasma-concentration time curve from time 0 through the last measurable concentration (AUC0-t) of H3B-6527Open-label · Basic sciencePhase 1CompletedDrug: H3B-6527Healthy Participants172018-01-27actual2018-02-07
Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.NCT02371174observationalNumber of participants with adverse events and serious adverse eventsCompletedBreast Cancer, HER2-negative Breast Cancer6512018-01-21actual2018-07-13
Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and OlderNCT03008447Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdoseRandomized · Triple-masked · OtherPhase 1CompletedDrug: LEM5, LEM10, ZOL, PBOHealthy Subjects602018-01-03actual2019-08-01
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type ANCT02175719observationalWhole improvement levelCompletedCervical Dystonia1502017-12-31actual2018-07-11
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy SubjectsNCT02873156Maximum drug concentration (Cmax)Randomized · Quadruple-masked · Basic sciencePhase 1CompletedDrug: E2027, E2027 matched placeboHealthy Subjects742017-11-29actual2018-09-07
Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose AspirinNCT02423187observationalIncidence of adverse drug reactionsCompletedOther: No InterventionGastric Ulcer, Duodenal Ulcer1,5682017-10-30actual2018-08-28
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult SubjectsNCT03082235Number of participants with any serious adverse event and number of participants with any non-serious adverse eventRandomized · Triple-masked · Basic sciencePhase 1CompletedDrug: E6742, PlaceboHealthy Participants722017-10-11actual2018-09-07
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and TaxanesNCT02225470Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progressionRandomized · Open-label · TreatmentPhase 3CompletedDrug: E7389 (Eribulin Mesylate), Vinorelbine injectionHER2-Negative Breast Cancer, Triple Negative Breast Cancer, Breast Cancer, Cancer of Breast, Breast Tumors5302017-09-29actual2018-08-28
A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's LymphomaNCT03009344results2022-11-10Number of Participants With Dose-limiting Toxicities (DLTs)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: TazemetostatRelapsed or Refractory B-cell Non-Hodgkin's Lymphoma72017-07-12actual2022-11-10
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein BindingNCT02998775Number of participants with any serious adverse event and any non-serious adverse eventNon-randomized · Open-label · Basic scienceEarly Phase 1CompletedDrug: Plasma SamplingHepatic Impairment; Renal Impairment542017-07-08actual2018-09-07
A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With EpilepsyNCT04230044observationalNumber of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)CompletedDrug: PerampanelEpilepsy, Partial-onset Seizures1172017-07-03actual2020-01-18
Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)NCT02953743Mean maximum observed concentration (Cmax)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: LenvatinibUnresectable Hepatocellular Carcinoma (HCC)252017-06-28actual2021-04-01
Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)NCT02454478results2019-02-08Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1CompletedDrug: Lenvatinib, EverolimusCarcinoma, Renal Cell72017-05-29actual2019-03-19
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)NCT02345213Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)Randomized · Triple-masked · TreatmentPhase 4CompletedDrug: E2020, PlaceboDementia, Lewy Body, Lewy Body Disease1602017-05-15actual2019-01-08
A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)NCT00445172Number of participants with Adverse Events as a Measure of safetyOpen-label · TreatmentPhase 2/3CompletedDrug: E0302 (mecobalamin)Amyotrophic Lateral Sclerosis (ALS)1352017-03-31actual2023-06-18
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).NCT02448784observationalMean Mini-Mental State Examination (MMSE) scoreCompletedDrug: Donepezil HydrochlorideDementia With Lewy Body Disease5912017-03-30actual2018-07-11
Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese SubjectsNCT03055962Number of participants with any serious adverse event and number of participants with any non-serious adverse eventRandomized · Triple-masked · Basic sciencePhase 1CompletedDrug: E2609, PlaceboHealthy Participants162017-03-29actual2017-04-18
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730NCT03054194Number of participants with any serious adverse event and number of participants with any non-serious adverse eventRandomized · Triple-masked · TreatmentPhase 1CompletedDrug: E2730, PlaceboHealthy Participants82017-03-02actual2018-09-07
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly SubjectsNCT02583451Change of standard deviation of lateral position (SDLP) during an on-road driving testRandomized · Double-masked · Basic sciencePhase 1CompletedDrug: Placebo tablet matching lemborexant, Placebo tablet matching zopiclone, Zopiclone 7.5 mg, Lemborexant 2.5 mg, Lemborexant 5 mg, Lemborexant 10 mgHealthy Participants482017-01-31actual2018-09-06
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective ProcedureNCT01976104results2018-02-27Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled ProcedureRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: avatrombopag (lower baseline platelet count), placebo (lower baseline platelet count), avatrombopag (higher baseline platelet count), placebo (higher baseline platelet count)Thrombocytopenia Associated With Liver Disease2042017-01-30actual2018-02-27
Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective ProcedureNCT01972529results2018-02-27Percentage of Participants Who Did Not Require a Platelet Transfusion or Any Rescue Procedure for Bleeding After Randomization Following a Scheduled ProcedureRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: avatrombopag (lower baseline platelet count), placebo (lower baseline platelet count), avatrombopag (higher baseline platelet count), placebo (higher baseline platelet count)Thrombocytopenia Associated With Liver Disease2312017-01-26actual2018-02-27
Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid TumorsNCT02686164results2019-08-28AUC(0-24): Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose for Midazolam and 1'-HydroxymidazolamOpen-label · TreatmentPhase 1CompletedDrug: Lenvatinib, MidazolamTumors512017-01-04actual2019-08-28
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast CancerNCT02481050results2018-11-15Objective Response Rate (ORR) by Investigator AssessmentOpen-label · TreatmentPhase 2CompletedDrug: Eribulin MesylateBreast Cancer582016-12-31actual2018-11-15
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy SubjectsNCT02859207Mean maximum plasma concentration (Cmax) of E2609Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E2609Early Alzheimer's Disease322016-12-06actual2017-06-08
Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy SubjectsNCT02947711Number of participants with any adverse event (AE) and any serious adverse event (SAE)Open-label · TreatmentPhase 1CompletedDrug: E2027, Diltiazem ERHealthy Subjects16Nov 2016actual2017-03-07
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination ChemotherapyNCT02579616results2020-12-23Objective Response Rate (ORR)Open-label · TreatmentPhase 2CompletedDrug: LenvatinibBiliary Tract Cancer292016-11-22actual2020-12-23
A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular CarcinomaNCT01761266results2018-09-25Overall Survival (OS)Randomized · Open-label · TreatmentPhase 3CompletedDrug: Lenvatinib, SorafenibHepatocellular Carcinoma (HCC)9542016-11-13actual2022-04-05
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)NCT02430714observationalNumber of participants with adverse events (AEs)/adverse drug reactions (ADRs)CompletedDrug: LenvatinibThyroid Neoplasms6292016-11-06actual2020-01-09
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy SubjectsNCT02427607results2018-07-02Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of PerampanelOpen-label · TreatmentPhase 3CompletedDrug: PerampanelEpilepsy72016-09-21actual2018-07-02
A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living.NCT02094053Changes in total scores from baseline using Body Functionality Checklist (psychosomatic function questionnaire) in subjects with Down syndrome having regression symptoms and disabled activities of daily living (ADL), relative to placebo.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: E2020-Donepezil hydrochloride, E2020-Donepezil hydrochloride, PlaceboDown Syndrome362016-09-16actual2017-08-22
To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset SeizuresNCT02220972Change from baseline in latency to persistent sleep (LPS) using Polysomnography (PSG)Randomized · Double-masked · TreatmentPhase 4WithdrawnDrug: Perampanel, PlaceboEpilepsy, Partial0Aug 20162015-02-10
Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy SubjectsNCT02809768Mean maximum observed concentration (Cmax)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: Avatrombopag, Fluconazole, Itraconazole, RifampinHealthy Participants48Aug 2016actual2017-03-09
A Study of E6011 in Japanese Subjects With Rheumatoid ArthritisNCT02196558results2020-08-13Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Non-randomized · Open-label · TreatmentPhase 1/2CompletedDrug: E6011Arthritis, Rheumatoid532016-08-12actual2020-08-13
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)NCT00903786results2018-08-29Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of PerampanelOpen-label · TreatmentPhase 2CompletedDrug: perampanelRefractory Partial Seizures212016-08-08actual2018-08-29
A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)NCT01773434Tolerability and SafetyOpen-label · TreatmentPhase 1CompletedDrug: MORAb-004Solid Tumor46Jul 2016actual2016-11-10
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade GliomaNCT02300506observationalSurvival rateCompletedOther: No interventionMalignant Glioma5072016-07-10actual2018-11-05
Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult SubjectsNCT02415790Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · TreatmentPhase 1CompletedDrug: E2027, E2027 matching placeboHealthy Participants112Jun 2016actual2017-03-08
Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With EpilepsyNCT02736162observationalRetention rateCompletedOther: No treatment (intervention) was administeredEpilepsy, Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures61Jun 2016actual2017-03-09
A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease PatientsNCT02135107results2018-11-19Rate of Non-recurrence at Week 52Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Rabeprazole, Rabeprazole, Rabeprazole, RabeprazoleGastroesophageal Reflux Disease517May 2016actual2023-06-22
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseNCT02249078Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of the short-term safety and tolerability of E6011Randomized · Double-masked · TreatmentPhase 1WithdrawnDrug: E6011, PlaceboCrohn's Disease0Mar 20162015-11-05
Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter PyloriNCT01264822observationalResponse rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pyloriCompletedDrug: Rabeprazole SodiumGastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive1082016-02-29actual2017-02-27
Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the LungNCT01877083results2019-08-13Objective Response Rate (ORR)Open-label · TreatmentPhase 2CompletedDrug: LenvatinibKIF5B-RET-Positive Adenocarcinoma of the Lung252016-02-03actual2019-08-13
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and NeckNCT01332266results2022-01-03Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)Randomized · Open-label · TreatmentPhase 1/2CompletedDrug: E7050, CetuximabPlatinum-Resistant Squamous Cell Carcinoma of the Head and Neck952016-01-31actual2022-01-03
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including LymphomasNCT02171260results2018-12-24Maximum Tolerated Dose (MTD) of Eribulin MesylateOpen-label · TreatmentPhase 1CompletedDrug: Eribulin MesylatePediatrics, Solid Tumors232016-01-28actual2019-01-15
A Study of APD356 (Lorcaserin) in Healthy Japanese Adult SubjectsNCT02192515Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: APD356 10 mg, APD356 XR-20 mg, APD356 10 mg matching Placebo, APD356 XR-20 mg matching Placebo, APD356 20 mg, APD356 20 mg matching Placebo, APD356 XR-20 mg (orange tablet), APD356 XR-20mg (orange tablet, fed state)Healthy Subjects40Nov 2015actual2016-02-10
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic DrugsNCT01405053results2019-08-06Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment PeriodRandomized · Open-label · TreatmentPhase 3CompletedDrug: Rufinamide, Any other approved Antiepileptic DrugLennox-Gastaut Syndrome372015-11-02actual2019-08-06
An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients With Solid TumorsNCT01945710results2019-07-23Maximum Tolerated Dose (MTD) of Eribulin-LFNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: Eribulin-LFSolid Tumors62Oct 2015actual2019-07-23
European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)NCT01991041observationalSafety during the use of rufinamide and other anti-epileptic drugsCompletedLennox-Gastaut Syndrome109Oct 2015actual2016-05-04
Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational RegistryNCT02443428observationalNumber of participants with adverse events (AEs) and serious adverse events (SAEs)CompletedBreast Cancer77Oct 2015actual2016-04-15
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's DiseaseNCT01251718observationalADAS-Jcog (test of cognitive function)CompletedDrug: donepezil hydrochlorideAlzheimer's Disease8942015-10-14actual2023-07-24
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-NCT01129596observationalThe transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiationCompletedDrug: donepezil hydrochlorideAlzheimer's Disease10,2382015-09-25actual2018-11-05
E7777 for the Treatment of Patients With Peripheral T-Cell LymphomaNCT01401530results2018-11-23Maximum Tolerated Dose (MTD) and Recommended Dose (RD)Open-label · TreatmentPhase 1CompletedBiological: denileukin diftitox (E7777)Peripheral T-Cell Lymphoma13Aug 2015actual2018-11-23
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid CancerNCT02211222expanded accessApproved for marketingDrug: LenvatinibDifferentiated Thyroid CancerAug 20152016-03-16
An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid TumorsNCT01618136Phase 1 To determine the maximum tolerated dose of E7449 as a single agentNon-randomized · Open-label · TreatmentPhase 1/2CompletedDrug: E7449 alone, E7449 plus TMZ, E7449 plus carboplatin and paclitaxelMalignant Solid Tumour, Ovarian Cancer, Triple Negative Breast Cancer, Advanced Melanoma, B-cell Malignancy, Low-grade41Jul 2015actual2023-06-18
Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male SubjectsNCT02268838Safety and tolerability of E6007 as a measure of Adverse eventsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: E6007, E6007 matching placeboHealthy Volunteers24Jul 2015actual2016-01-20
A Study of E7080 in Subjects With Advanced Thyroid CancerNCT01728623results2020-08-14Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentPhase 2CompletedDrug: E7080 capsuleThyroid Cancer512015-07-09actual2020-08-14
E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular CarcinomaNCT01271504results2021-04-08Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)Randomized · Open-label · TreatmentPhase 1/2CompletedDrug: Sorafenib, SorafenibHepatocellular Carcinoma1022015-06-23actual2021-05-12
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal CancerNCT01347645results2022-11-25Phase 1b: Maximum Tolerated Dose (MTD) of E7820 With Irinotecan as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0Randomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: The study was terminated by the Sponsor due to E7820 plus irinotecan being potentially inferior to FOLFIRIDrug: FOLFIRI, E7820Colon Cancer, Rectal Cancer822015-06-22actual2023-06-22
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical PracticeNCT02162264observationalChange From Baseline in the Mini-Mental State Examination (MMSE) ScoreCompletedDrug: Donepezil HydrochlorideAlzheimer's Disease8,6622015-05-30actual2018-09-07
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular CarcinomaNCT02269995observationalSafety and Tolerability as measured by Adverse EventsCompletedDevice: E7040Hepatocellular Carcinoma3002015-05-14actual2018-11-05
Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder CancerNCT01126749results2022-02-28Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0Randomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Study was terminated as per sponsor's decisionDrug: Gemcitabine, E7389, CisplatinBladder Cancer922015-05-08actual2022-02-28
Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's DiseaseNCT02162251observationalInvestigations on adverse events and adverse drug reactionsCompletedDrug: Donepezil HydrochlorideAlzheimer's Desease3,4822015-05-01actual2018-09-07
A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of AgeNCT02398669Plasma PK profile of lorcaserin and its primary metabolites (M1 and M5)Open-label · TreatmentPhase 1CompletedDrug: Lorcaserin hydrochlorideObesity10Apr 2015actual2015-11-03
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia DisorderNCT02350309results2020-01-18Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3Randomized · Double-masked · TreatmentPhase 1CompletedDrug: Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant-matched placebo., Flurazepam 30 mgInsomnia Disorder692015-04-21actual2020-01-18
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV MelanomaNCT01127451results2022-04-13Percentage of Participants With Immune-related Overall Response Rate (irORR)Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: Denileukin diftitoxStage IIIC Melanoma, Stage IV Melanoma752015-04-07actual2022-04-13
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and ThrombocytopeniaNCT02227693results2019-02-28Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4Randomized · Double-masked · TreatmentPhase 2CompletedDrug: avatrombopag, PlaceboThrombocytopenia Associated With Chronic Liver Disease392015-04-01actual2019-02-28
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer RefractoryNCT01240421expanded accessApproved for marketingDrug: Eribulin MesylateMetastatic Breast CancerMar 20152015-05-22
A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's DiseaseNCT02094729Number of Participants with Adverse Events as a Measure of Safety and TolerabilityRandomized · Double-masked · TreatmentPhase 1CompletedDrug: BAN2401 2.5 mg/kg, BAN2401 5 mg/kg, BAN2401 10 mg/kg, PlaceboAlzheimer's Disease26Mar 2015actual2015-06-08
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia PatientsNCT02455271observationalAssessment of overall improvementCompletedDrug: EszopicloneInsomnia4382015-03-30actual2018-09-07
A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2)NCT01433991results2021-06-08Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination TreatmentRandomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Study was terminated by the sponsor early at the end of Phase 1b due to a change in corporate strategy.Drug: Golvatinib, Lenvatinib, LenvatinibAdvanced Solid Tumors302015-03-18actual2021-06-08
A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese SubjectsNCT02289599Number of adverse events/serious adverse eventsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: E2307, E2307 Matching PlaceboHealthy Subjects24Feb 2015actual2016-01-18
Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's DiseaseNCT01539031The Severe Impairment Battery (SIB)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: E2020, E2020Alzheimer's Type Dementia351Jan 2015actual2023-06-18
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled StudyNCT01645800Acute exacerbation of COPDRandomized · Double-masked · TreatmentPhase 4CompletedDrug: Lysozyme hydrochloride, PlaceboCOPD408Jan 2015actual2015-10-21
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue SarcomaNCT01327885results2017-02-28Overall Survival (OS)Randomized · Open-label · TreatmentPhase 3CompletedDrug: Eribulin mesylate 1.4 mg/m^2 intravenous, Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IVSoft Tissue Sarcoma4522015-01-02actual2023-06-22
A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly MalesNCT02225288Number and frequency of adverse eventsRandomized · Open-label · TreatmentPhase 1CompletedDrug: E2022Healthy Subjects48Dec 2014actual2015-04-02
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy SubjectsNCT02279485Pharmacokinetics of Perampanel: AUC(0-t)Randomized · Double-masked · TreatmentPhase 1CompletedDrug: PerampanelHealthy Subjects100Dec 2014actual2015-11-03
An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma (Study E7389-J081-217)NCT01458249results2016-03-28Progression-free Rate at 12 Weeks (PFR12wks)Open-label · TreatmentPhase 2CompletedDrug: eribulin mesylateSoft Tissue Sarcoma52Nov 2014actual2016-03-28
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia PatientsNCT02452684observationalAssessment of overall improvementCompletedDrug: EszopicloneInsomnia4,8762014-11-11actual2018-09-07
A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell LymphomaNCT01355783To evaluate whether treatment of E7777 in combination with CHOP chemotherapy has superior efficacy compared with CHOP alone in improving progression-free survival (PFS) in first line treatment of subjects with peripheral T-cell lymphomaRandomized · Open-label · TreatmentPhase 3WithdrawnDrug: E7777Peripheral T-Cell Lymphoma0Oct 20142013-11-18
A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy SubjectsNCT02222324Change from baseline in QTcF obtained from ECGs extracted from the Holter recordingsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: Placebo, E2609, MoxifloxacinHealthy Subjects60Oct 2014actual2015-11-03
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast CancerNCT01328249results2018-09-26Percentage of Participants With FeasibilityOpen-label · TreatmentPhase 2CompletedDrug: eribulin mesylateHER2-normal812014-10-27actual2019-08-20
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial SeizuresNCT00735397results2016-01-26Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)Open-label · TreatmentPhase 3CompletedDrug: perampanelEpilepsy1,218Sep 2014actual2016-03-14
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset SeizuresNCT01618695results2020-06-05Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Perampanel, PlaceboPartial-onset Seizures9402014-09-15actual2021-07-29
A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese AdultsNCT01987427results2019-09-30Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic ReactionRandomized · Double-masked · TreatmentPhase 4CompletedDrug: lorcaserin + phentermine placebo, lorcaserin + phentermine-HCl + phentermine placebo, lorcaserin + phentermine-HClChronic Weight Management344Aug 2014actual2019-09-30
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White SubjectsNCT02207790Pharmacokinetics of E2609: CmaxRandomized · Double-masked · TreatmentPhase 1CompletedDrug: E2609, PlaceboHealthy Subjects32Aug 2014actual2015-11-03
Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy VolunteersNCT02792829results2019-03-14Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))Randomized · Open-label · TreatmentPhase 1CompletedDrug: LenvatinibHealthy Volunteers60Aug 2014actual2019-03-14
A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's DiseaseNCT01404169The change in the total Severe Impairment Battery (SIB) score at Week 24Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: E2020, PlaceboAlzheimer's Type Dementia260Jul 2014actual2017-03-08
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal FunctionNCT01418677To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7389, E7389, E7389Unspecified Adult Solid Tumor, Protocol Specific19Jul 2014actual2016-05-17
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male SubjectsNCT02116907Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects.Open-label · TreatmentPhase 1CompletedDrug: E2007Healthy Subjects7Jul 2014actual2015-11-03
A Confirmation Study of Eribulin in Combination With CapecitabineNCT01323530results2021-01-11Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)Non-randomized · Open-label · TreatmentPhase 1/2CompletedDrug: Eribulin mesylate, CapecitabineMetastatic Breast Cancer762014-07-28actual2021-01-11
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)NCT02300532observationalNumber of Adverse Events/Serious Adverse EventsCompletedOther: No interventionMalignant Glioma5612014-07-10actual2017-02-27
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial SeizuresNCT00368472results2015-12-10Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)Open-label · TreatmentPhase 2CompletedDrug: PerampanelEpilepsy138Jun 2014actual2015-12-10
E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV MelanomaNCT01133977results2016-10-10Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)Randomized · Open-label · TreatmentPhase 1/2CompletedDrug: Lenvatinib, Lenvatinib, DacarbazineStage IV Melanoma97Jun 2014actual2016-10-10
A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White SubjectsNCT02039076Pharmacokinetic (PK) profiles of avatrombopagRandomized · Open-label · TreatmentPhase 1CompletedDrug: avatrombopagThrombocytopenia48Jun 2014actual2014-12-18
Extended Treatment in Metastatic Breast Cancer With EribulinNCT02769364observationalOverall survivalCompletedBreast Cancer45Jun 2014actual2023-07-24
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)NCT00946153results2019-02-01Phase 1: Maximum Tolerated Dose (MTD) of LenvatinibNon-randomized · Open-label · TreatmentPhase 1/2CompletedDrug: LenvatinibHepatocellular Carcinoma662014-06-15actual2019-02-01
A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted TreatmentNCT01136733results2019-02-27Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT)Randomized · Open-label · TreatmentPhase 1/2CompletedDrug: Lenvatinib, EverolimusMetastatic Renal Cell Carcinoma1732014-06-13actual2019-02-27
A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic SeizuresNCT01393743results2016-01-11Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Perampanel, Placebo comparatorSeizure Disorder Generalized Tonic Clonic163May 2014actual2017-08-28
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic DrugsNCT01527006results2015-08-28Apparent Clearance (CL/F) of Perampanel [Core Study]Open-label · TreatmentPhase 2CompletedDrug: perampanelCentral Nervous System63May 2014actual2016-07-12
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White SubjectsNCT02039089Pharmacokinetic (PK) profiles of E2006Randomized · Double-masked · TreatmentPhase 1CompletedDrug: E2006 2.5 mg, E2006 10 mg, E2006 25 mg, PlaceboHealthy Volunteers32May 2014actual2015-11-03
A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy SubjectsNCT02089412Pharmacokinetics of E2006: AUC(t-0)Randomized · Open-label · TreatmentPhase 1CompletedDrug: E2006Healthy Subjects59May 2014actual2015-11-03
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung CancerNCT01454934results2017-03-01Overall Survival (OS)Randomized · Open-label · TreatmentPhase 3CompletedDrug: Eribulin, TPC -Vinorelbine,Gemcitabine,Docetaxel, and PemetrexedNon-Small Cell Lung Cancer (NSCLC)5402014-05-30actual2023-06-22
An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820 to Determine the Maximum Tolerated Dose Following Twice Daily Oral Administration in Subjects With Unresectable Solid TumorsNCT01773421results2020-01-18Treatment Phase Part A: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for E7820Randomized · Open-label · TreatmentPhase 1CompletedDrug: E7820, E7820Advanced Solid Tumors452014-04-30actual2023-06-22
An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male SubjectsNCT02046213Pharmacokinetics: Excretion of E2006: urine/feces concentrationNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: E2006Metabolism and Excretion16Apr 2014actual2015-11-03
A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or DonepezilNCT02055703To evaluate the pharmacokinetics (PK) of single oral doses of E2609 and metabolites in subjects dosed alone or in combination with either rifampin or itraconazoleRandomized · Open-label · TreatmentPhase 1CompletedDrug: E2609, itraconazole, rifampin, digoxin, donepezilHealthy Subjects195Apr 2014actual2015-11-03
A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or BupropionNCT02085967Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): AUC(0-t)Randomized · Open-label · TreatmentPhase 1CompletedDrug: rifampin 600 mg, itraconazole 200 mg, midazolam 2 mg with bupropion 75 mg, E2006Healthy Subjects106Apr 2014actual2015-11-03
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic InsomniaNCT01995838results2020-01-31Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian AnalysisRandomized · Double-masked · TreatmentPhase 2CompletedDrug: E2006, PlaceboChronic Insomnia, Adults, Elderly2912014-04-29actual2020-01-31
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid ArthritisNCT01850966observationalDisease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)CompletedDrug: IguratimodRheumatoid Arthritis2,7472014-04-13actual2018-11-05
A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)NCT00444613Survival rateRandomized · Double-masked · TreatmentPhase 2/3CompletedDrug: E0302 (mecobalamin), E0302 (mecobalamin), PlaceboAmyotrophic Lateral Sclerosis (ALS)373Mar 2014actual2023-06-18
A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)NCT01830400observationalRetention Rate of Eslicarbazepine Acetate (ESL) After 6 months from BaselineCompletedDrug: Eslicarbazepine Acetate tabletsPartial Onset Seizures254Mar 2014actual2015-08-19
A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy SubjectsNCT02020486Pharmacokinetics (PK) of perampanel in Korean healthy male subjectsNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: Perampanel, PerampanelHealthy20Mar 2014actual2015-03-03
Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501NCT01355289results2018-02-22Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core StudyRandomized · Triple-masked · TreatmentPhase 2CompletedDrug: Avatrombopag, Placebo, Pegylated interferon (PEG-IFN), Telaprevir, RibavirinThrombocytopenia65Feb 2014actual2018-02-22
Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III MelanomaNCT01605162The Progression Free Survival-6m rate defined as the proportion of subjects that are alive and progression-free at 6-months from the date of first dosing based on RECIST 1.1.Open-label · TreatmentPhase 2TerminatedDrug: TMZ, E7016Wild Type BRAF Stage IV Melanoma, Unresectable Stage III Melanoma8Feb 2014actual2016-07-28
A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different TreatmentsNCT01529112results2016-02-18Overall Survival (OS)Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Lenvatinib, Lenvatinib matched placebo, BSCNon-Small Cell Lung Cancer1352014-01-21actual2017-09-26
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)NCT01398410results2015-11-16Percentage of Participants With Treatment Emergent Adverse Events (AEs)Randomized · Open-label · PreventionPhase 2/3CompletedDrug: Rabeprazole, RabeprazoleGastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin405Dec 2013actual2015-12-21
A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous MalformationNCT01677624results2016-02-22Success Rate of Embolization in the Target VesselOpen-label · TreatmentPhase 3CompletedDevice: E7040Hypervascular Tumor and Arteriovenous Malformation28Dec 2013actual2016-02-22
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum SymptomNCT01715493Change of several inflammatory or biochemical marker concentration in inducted sputumRandomized · Double-masked · TreatmentPhase 4CompletedDrug: lysozyme 90 mg, PlaceboChronic Obstructive Pulmonary Disease, Asthma48Dec 2013actual2014-07-18
Single Dose Study to Determine the Safety, Tolerability, and Pharmacokinetic Properties of Lorcaserin Hydrochloride (BELVIQ) in Obese Adolescents From 12 to 17 Years of AgeNCT02022956Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)Open-label · OtherPhase 1CompletedDrug: LorcaserinPharmacokinetics in Obese Adolescents8Dec 2013actual2019-09-17
A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male SubjectsNCT02146261Pharmacokinetics of E6011: Maximum Concentration (Cmax)Randomized · Double-masked · TreatmentPhase 1CompletedDrug: E6011, PlaceboHealthy32Dec 2013actual2014-10-22
Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic MelanomaNCT01335009results2021-09-01Percentage of Participants With Progression-free Survival (PFS) at Week 24Randomized · Open-label · TreatmentPhase 2CompletedBiological: MORAb-004 (monoclonal antibody)Metastatic Melanoma762013-12-02actual2021-09-01
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)NCT01438840results2018-01-05Number of Weeks With Platelet Count Greater Than or Equal to 50 x 10^9/L During 6-Month Treatment PeriodRandomized · Triple-masked · TreatmentPhase 3CompletedDrug: Avatrombopag, Placebo, Standard of careChronic Thrombocytopenia, Immune Thrombocytopenia49Nov 2013actual2018-02-05
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male SubjectsNCT01975636Pharmacokinetics: Elimination of E2609: urine/feces concentrationOpen-label · TreatmentPhase 1CompletedDrug: E2609Metabolism and Elimination113Nov 2013actual2016-01-08
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)NCT01321554results2016-12-12Progression Free Survival (PFS)Randomized · Triple-masked · TreatmentPhase 3CompletedDrug: Lenvatinib, Placebo, LenvatinibThyroid Cancer3922013-11-15actual2023-06-22
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)NCT01433978results2018-02-06Change From Baseline in Local Platelet Count for the 6 Month Treatment PeriodRandomized · Triple-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Study was terminated early due to significant enrollment challenges.Drug: Eltrombopag, Avatrombopag, Standard of careIdiopathic Thrombocytopenic Purpura24Sep 2013actual2018-02-06
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)NCT01600859Percent change from baseline in cerebrospinal fluid amyloid-beta levelsRandomized · Triple-masked · TreatmentPhase 1CompletedDrug: E2609, Placebo for E2609Alzheimer's Disease65Sep 2013actual2016-12-30
A Long Term Extension Study of E2080 in Lennox-Gastaut PatientsNCT01151540results2019-03-11Number of Participants With Adverse Events as a Measure of Safety and Tolerability of RufinamideOpen-label · TreatmentPhase 3CompletedDrug: RufinamideLennox-Gastaut Syndrome54Aug 2013actual2019-03-11
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast CancerNCT01432886results2015-03-30Number of Participants With Dose Limiting Toxicity (DLT)Open-label · TreatmentPhase 1CompletedDrug: E7389Breast Cancer12Aug 2013actual2016-10-07
A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)NCT01731275Number of Participants with Adverse EventsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: E6011, E6011 Matching PlaceboHealthy Male Volunteers64Aug 2013actual2014-02-14
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy VolunteersNCT02723630results2019-03-14Area Under the Plasma Concentration-Time Curve From Zero Time (Predose) to Time of Last Quantifiable Concentration (AUC(0-t))Randomized · Open-label · TreatmentPhase 1CompletedDrug: Lenvatinib 10 mgHealthy Volunteers60Aug 2013actual2019-03-14
A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)NCT01774773Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed ConditionsRandomized · Open-label · TreatmentPhase 1CompletedDrug: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg, Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg, Group C: E5501 40mg, then 5mg, then 20 mg, then 5mgHealthy15Jul 2013actual2014-02-03
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) SubjectsNCT01177540results2022-06-28Percentage of Participants With Morphologic Complete Remission (CR)Randomized · Open-label · TreatmentPhase 2Terminatedsponsor's stated reason: The study was terminated early due to enrollment difficulties and the futility of observing differences in remission rate between treatment arms.Drug: Decitabine, DecitabinePediatric Acute Myelogenous Leukemia (AML)252013-07-19actual2022-06-28
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in AdolescentsNCT01161524results2019-05-15Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study)Randomized · Open-label · TreatmentPhase 2CompletedDrug: Perampanel, PlaceboEpilepsy133Jun 2013actual2019-05-15
A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)NCT01830868observationalRetention Rate of Zonisamide (ZNS) after 6 months from BaselineCompletedDrug: Zonisamide tabletsPartial Onset Seizures104Jun 2013actual2023-06-18
2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly SubjectsNCT01673451Incidence of Adverse events (AEs)Randomized · Double-masked · TreatmentPhase 1CompletedDrug: E2006, Placebo comparatorCNS24May 2013actual2013-10-11
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast CancerNCT00879086results2021-12-01Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)Randomized · Open-label · TreatmentPhase 2CompletedDrug: Eribulin Mesylate, IxabepiloneBreast Cancer1042013-04-30actual2023-06-22
An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV MelanomaNCT01136967results2016-03-16Objective Response Rate (ORR)Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: LenvatinibUnresectable Stage III, Stage IV Melanoma182Apr 2013actual2019-11-13
E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric CancerNCT01355302results2017-03-13Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of GolvatinibRandomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Sites not recruitingDrug: E7050, cisplatin, capecitabineAdvanced or Metastatic Solid Tumors, Previously Untreated Gastric Cancer7Apr 2013actual2017-05-15
A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly MalesNCT01843556Number and frequency of adverse eventsNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: E2022 Tape FormulationHealthy Elderly Male48Apr 2013actual2023-06-18
Dose-Finding Study of E7070 in Combination With IrinotecanNCT00060567To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7070 + irinotecan combination, Irinotecan + E7070 combination, Irinotecan + E7070 combinationCancer88Mar 2013actual2023-06-18
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast CancerNCT01269346results2017-03-30Objective Response RateOpen-label · TreatmentPhase 2CompletedDrug: Eribulin MesylateBreast Cancer52Mar 2013actual2023-06-22
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension PhaseNCT01278407results2015-11-30Change From Baseline in Mini-Mental State Examination (MMSE) ScoreRandomized · Triple-masked · TreatmentPhase 3CompletedDrug: Donepezil 5 mg, Donepezil 10 mg, Donepezil matched placeboDementia With Lewy Bodies (DLB)142Mar 2013actual2023-06-29
Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)NCT01397448results2014-10-23Cumulative Recurrent Rates of Gastric or Duodenal UlcersRandomized · Quadruple-masked · PreventionPhase 2/3CompletedDrug: E3810, E3810, TeprenoneGastric or Duodenal Ulcers Caused by Low-dose Aspirin472Mar 2013actual2014-11-26
A Study in Subjects With Recurrent Malignant GliomaNCT01137604results2016-05-23Progression Free Survival (PFS) Rate at Month 6Randomized · Open-label · TreatmentPhase 2CompletedDrug: Lenvatinib, BevacizumabGlioma1512013-03-19actual2022-09-29
Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux EsophagitisNCT01321567observationalNumber of subjects with improvement based on health related Quality of Life (QOL) questionnaireCompletedDrug: rabeprazole sodiumRefractory Reflux Esophagitis2,1572013-03-01actual2023-07-24
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric UlcerNCT01190657Endoscopic results of ulcer lesionNon-randomized · Open-label · TreatmentPhase 4CompletedDrug: Selbex, SelbexAcute Gastritis, Gastric Ulcer1,184Feb 2013actual2013-04-01
The Effect of Vitamin K2 on Bone TurnoverNCT00548509Gamma-carboxylationRandomized · Open-label · TreatmentPhase 4CompletedDrug: Menatetrenone (Vitamin K2)Osteoporosis131Jan 2013actual2018-10-29
Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor PolyneuropathyNCT00927914Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other.Randomized · Double-masked · TreatmentPhase 2/3CompletedDrug: Ranirestat, PlaceboMild to Moderate Diabetic Sensorimotor Polyneuropathy800Jan 2013actual2019-02-21
A Study of MORAb-003 in Patients With Solid TumorNCT01049061To investigate dose-limiting toxicity and estimate maximum tolerated dose.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: MORAb-003Neoplasms, Solid Tumor16Jan 2013actual2020-06-11
A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.NCT01283256observationalAssess safety with zonisamide therapy in adult patients with different seizure typesCompletedDrug: zonisamidePartial, Generalized and Combined Seizures655Jan 2013actual2014-01-27
A Phase I Study of E7050 in Subjects With Solid TumorsNCT01428141Determination of the maximum tolerated dose (MTD)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7050Solid Tumor, Gastric Cancer18Jan 2013actual2014-02-14
A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat MealNCT01759394Area under the plasma concentration-time course profile From Time = 0 to time extrapolated to infinity (AUC [0-inf])Randomized · Open-label · TreatmentPhase 1CompletedDrug: Avatrombopag maleate 40 mgHealthy Volunteers36Jan 2013actual2013-10-31
Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients With Stage IIIB or IV Nonsquamous Non Small Cell Lung CancerNCT01126736results2022-08-04Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)Randomized · Open-label · TreatmentPhase 1/2CompletedDrug: eribulin mesylate, pemetrexed, Eribulin mesylate (eribulin; E7389)Non Small Cell Lung Cancer982012-12-31actual2023-06-22
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on AbsorptionNCT01716897AUC(0-inf) ratio, new tablet vs. capsuleRandomized · Open-label · TreatmentPhase 1CompletedDrug: E2609Alzheimer's Disease18Dec 2012actual2013-05-22
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)NCT01463891observationalEffectiveness Diagnosed by ImagingCompletedDrug: Eribulin MesylateInoperable or Recurrent Breast Cancer9632012-12-26actual2023-07-24
Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast CancerNCT01439282results2016-06-20Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%Open-label · TreatmentPhase 2CompletedDrug: eribulin mesylate, capecitabineEstrogen Receptor Positive Tumor, Breast Cancer77Nov 2012actual2023-06-22
A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose StudyNCT01230853Single Ascending Dose (SAD)Randomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: Active Comparator: A, Placebo Comparator B, Active Comparator B, Placebo Comparator AAlzheimer's Disease80Oct 2012actual2020-11-23
A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed ProcedureNCT01309984Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: Lusedra, PropofolLactating Women10Oct 2012actual2015-11-03
Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule FormulationsNCT01673880Plasma concentrations of E2006 of tablet vs. capsule formulationsRandomized · Open-label · TreatmentPhase 1CompletedDrug: E2006Insomnia40Oct 2012actual2013-05-22
A Phase 1 Comparative Study of E2022 Current and New Patch FormulationsNCT02042729Number of Adverse EventsNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: E2022- Current Formula Tape, E2022- New Formula Tape, E2022 Matching Placebo- Current Formula Tape, E2022 Matching Placebo- New Formula TapeHealthy34Oct 2012actual2014-02-21
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy SubjectsNCT02199379Pharmacokinetics of lenvatinib: CmaxNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: LenvatinibRenal Impairment, Disease Severity26Oct 2012actual2015-04-14
A Dose-Finding Study of E7050 Administered Orally to Patients With Advanced Solid TumorsNCT00869895Maximum Tolerated Dose: the highest dose at which no more than 1 out of 6 patients experiences Dose Limiting Toxicity (DLT) during Cycle 1.Open-label · TreatmentPhase 1CompletedDrug: E7050Cancer60Aug 2012actual2016-01-29
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006NCT01463098results2020-01-18Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)Randomized · Triple-masked · TreatmentPhase 1CompletedDrug: E2006 1.0 mg, E2006 2.5 mg, E2006 5.0 mg, E2006 10.0 mg, E2006 25.0 mg, E2006 50.0 mg, E2006 100 mg, E2006 200 mg, Zolpidem 10 mg, E2006 Matched Placebo or Zolpidem Matched Placebo, E2006 Matched PlaceboInsomnia1222012-08-11actual2020-01-18
Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy SubjectsNCT01511783Incidence of adverse eventsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: E2609, PlaceboHealthy50Jul 2012actual2015-11-03
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.NCT02268812results2018-10-25observationalAverage Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)CompletedPain Management, Severe Chronic Pain219Jul 2012actual2018-10-25
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)NCT02421042Pharmacokinetics of lenvatinib: CmaxOpen-label · TreatmentPhase 1CompletedDrug: LenvatinibHepatic Impairment, Hepatic Function14Jul 2012actual2015-05-05
E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue SarcomaNCT00413192results2017-03-22Progression Free Survival (PFS) at 12 WeeksOpen-label · TreatmentPhase 2CompletedDrug: E7389Soft Tissue Sarcoma128Jun 2012actual2017-04-26
A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501NCT01549054Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMaxRandomized · Open-label · TreatmentPhase 1CompletedDrug: 10-mg dose of E5501 2G tablet, 10-mg dose of E5501 cyclodextrin oral solution, 10-mg dose of E5501-P21% powder, 10-mg dose of E5501 lipid-based oralIdiopathic Thrombocytopenic Purpura28Jun 2012actual2013-11-01
A Study of MORAb-009 in Patients With Solid TumorNCT01018784To investigate dose-limiting toxicity and estimate maximum tolerated dose.Open-label · TreatmentPhase 1CompletedDrug: MORAb-009Cancer, Mesothelin-positive17May 2012actual2016-01-21
Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease ProgressionNCT01111461results2016-04-18Objective Response Rate (ORR)Open-label · TreatmentPhase 2CompletedDrug: LenvatinibEndometrial Cancer133May 2012actual2023-06-22
A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type DementiaNCT01276353results2014-08-01Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3Randomized · Quadruple-masked · TreatmentPhase 2CompletedDrug: E2020, E2020Alzheimer's Type Dementia45Apr 2012actual2014-08-08
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)NCT00619099results2013-09-18The Overall Improvement RateRandomized · Open-label · TreatmentPhase 2CompletedDrug: decitabine, decitabineMyelodysplastic Syndrome67Mar 2012actual2013-10-24
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast CancerNCT01268150results2016-08-09Objective Response Rate (ORR)Open-label · TreatmentPhase 2CompletedDrug: Eribulin mesylateLocally Recurrent, Metastatic Breast Cancer ( HER2 Negative)56Mar 2012actual2023-06-22
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.NCT01437384Plasma concentrations of E5501Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E5501Idiopathic Thrombocytopenic Purpura (ITP)36Mar 2012actual2012-05-21
E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and TaxanesNCT00337103results2013-09-30Overall Survival (OS)Randomized · Open-label · TreatmentPhase 3CompletedDrug: Eribulin Mesylate, CapecitabineMetastatic Breast Cancer1,2762012-03-12actual2020-06-18
E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125NCT01133756results2016-12-05Number of Participants With Dose Limiting Toxicity (DLT)Randomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: poor accrualDrug: Lenvatinib, Carboplatin, GemcitabineOvarian Cancer7Feb 2012actual2023-06-22
A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)NCT01136954results2013-02-06Treatment Emergent Non-Serious Adverse Events With Greater Than 5% FrequencyOpen-label · TreatmentPhase 3CompletedDrug: ZonisamidePartial Seizures144Jan 2012actual2016-01-25
A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy VolunteersNCT02199392Pharmacokinetics of lenvatinib: CmaxOpen-label · TreatmentPhase 1CompletedDrug: LenvatinibP-glycoprotein, Healthy Volunteers15Jan 2012actual2015-02-16
A Study of E7080 in Subjects With Solid TumorNCT01268293results2015-03-06Number of Participants With Dose Limiting Toxicity (DLT)Open-label · TreatmentPhase 1CompletedDrug: E7080Cancer9Dec 2011actual2023-06-22
A Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid TumorsNCT00268905results2013-01-25Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7389 + carboplatin AUC 5, E7389 + carboplatin AUC 6, E7389+carboplatin AUC 6Cancer64Nov 2011actual2013-02-12
E7080 Food Effect Study in Healthy SubjectsNCT01240408To determine the effect of food on the bioavailability of lenvatinib.Randomized · Open-label · TreatmentPhase 1CompletedDrug: HOPE, HOPECancer16Nov 2011actual2015-03-04
E2022 Patch Formulation Multiple Dose StudyNCT01450839Composite (or Profile) of PharmacokineticsRandomized · Triple-masked · TreatmentPhase 1CompletedDrug: E2022, PlaceboHealthy16Nov 2011actual2012-06-01
Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic ProceduresNCT00914927results2018-01-23Percentage of Participants Experiencing ResponseRandomized · Double-masked · TreatmentPhase 2CompletedDrug: Avatrombopag, Avatrombopag, PlaceboThrombocytopenia Related to Chronic Liver Disease1302011-11-11actual2018-01-23
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy SubjectsNCT01221259To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.Randomized · Triple-masked · TreatmentPhase 1CompletedDrug: E2212, placeboAlzheimer's Disease60Oct 2011actual2013-05-22
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy SubjectsNCT01221818Evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjectsRandomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: E6007, E6007, E6007, E6007, E6007, E6007Inflammatory Bowel Disease48Oct 2011actual2014-07-11
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly CohortNCT01294540Safety and tolerability as evidenced by the number of subjects with adverse eventsRandomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: Drug: E2609, PlaceboAlzheimer's Disease73Oct 2011actual2013-08-29
Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese SubjectsNCT01390714Pharmacodynamic effect by ph monitoring will be evaluated.Randomized · Open-label · TreatmentPhase 1CompletedDrug: E3710, E3710Gastroesophageal Reflux Disease30Oct 2011actual2012-03-14
A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic MelanomaNCT00121680To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions.Open-label · TreatmentPhase 1CompletedDrug: E7080Metastatic Melanoma115Sep 2011actual2015-12-11
Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)NCT00941109Pharmacokinetic (PK) endpoints will be decitabine PK parameters: Tmax, Cmax, AUC0-inf, t1/2 and F.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: decitabine, decitabine, decitabine, decitabineMyelodysplastic Syndrome12Sep 2011actual2023-06-18
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateNCT00965757results2015-06-19Percentage of American College of Rheumatology [ACR] 20 Criteria RespondersRandomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: T-614, PlaceboRheumatoid Arthritis2532011-09-30actual2021-12-17
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult MalesNCT01506752PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.Randomized · Open-labelPhase 1CompletedDrug: Donepezil Hydrochloride, Donepezil Hydrochloride, Donepezil Hydrochloride, Donepezil HydrochlorideHealthy Adult20Sep 2011actual2012-06-27
A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) SubjectsNCT00943553Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteriaRandomized · Open-label · TreatmentPhase 2Withdrawnsponsor's stated reason: Terminated by SponsorDrug: decitabine Induction Chemotherapy, Induction ChemotherapyAcute Myelogenous Leukemia (AML)0Aug 2011actual2015-04-13
A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)NCT01089543results2013-11-19Rate of Complete Dyspepsia Symptom ReliefRandomized · Double-masked · TreatmentPhase 2CompletedDrug: Rabeprazole, Rabeprazole, Rabeprazole, PlaceboFunctional Dyspepsia338Aug 2011actual2013-12-24
Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed TherapiesNCT01142661results2013-09-20SafetyNon-randomized · Open-label · TreatmentNot applicableCompletedDrug: Eribulin MesylateBreast Cancer9Aug 2011actual2013-09-20
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)NCT01146951results2013-11-21Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Rufinamide (E2080), PlaceboLennox-Gastaut Syndrome66Aug 2011actual2018-01-24
Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 ActivityNCT01241669To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.Randomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: E5555, E5555Healthy Subjects104Aug 2011actual2014-07-11
A Study to Characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of LUSEDRA® Administered as Continuous Infusion or Bolus Compared With Continuous Infusion of Propofol Injectable EmulsionNCT01308541Arterial plasma levels of fospropofol and propofol during each treatment:Randomized · Open-label · TreatmentPhase 1CompletedDrug: arm 1, LUSEDRA, Propofol (arm 3)Monitored Anesthesia Care20Aug 2011actual2015-11-03
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc IntervalNCT01525394To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control.Randomized · Triple-masked · Basic sciencePhase 1CompletedDrug: Lenvatinib, Moxifloxacin 400 mg, Placebos (matched to 4 mg and 10 mg lenvatinib capsules).Refractory Solid Tumors, Lymphomas52Aug 2011actual2023-06-22
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid TumorsNCT00794781Maximum tolerated dose and dose-limiting toxicities as determined in Part A.Open-label · TreatmentPhase 1CompletedDrug: E6201Advanced Solid Tumors552011-08-01actual2022-10-14
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)NCT00832819results2015-03-06Maximum Tolerated Dose (MTD)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7080, E7080, Paclitaxel, CarboplatinNon-small-cell Lung Cancer28Jul 2011actual2015-04-30
Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial SeizuresNCT00848549results2013-01-15Percentage of Participants Remaining in the Study at Each VisitRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Zonisamide, CarbamazepineEpilepsy295Jun 2011actual2015-12-24
A Study of E7050 Administered Orally to Patients With Advanced Solid TumorsNCT00921869Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7050Solid Tumors16Jun 2011actual2017-12-26
A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special PopulationsNCT01127438results2013-02-08Number of Participants With Sedation SuccessRandomized · Triple-masked · TreatmentPhase 4CompletedDrug: fospropofol disodium Subgroup 1 Lower Dose, fospropofol disodium Subgroup 1 Approved Dose, fospropofol disodium Subgroup 2 Lower Dose, fospropofol disodium Subgroup 2 Approved Dose, fospropofol disodium Subgroup 3 Lower Dose, fospropofol disodium Subgroup 3 Approved DoseSedation153Jun 2011actual2013-02-08
A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back PainNCT01300312Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline.Randomized · Single-masked · TreatmentPhase 3CompletedDrug: Eperisone hydrochloride and Diclofenac sodium, Eperisone hydrochlorideAcute Musculoskeletal Spasm Due to Low Back Pain239Jun 2011actual2013-01-08
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic DrugNCT01630057Number of Participants with Adverse Events as a Measure of Safety and Tolerability in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapyRandomized · Open-label · TreatmentPhase 4CompletedDrug: Adjunctive Zonisamide, Replacement with ZonisamidePartial Seizures200Jun 2011actual2014-07-14
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy VolunteersNCT02198170Pharmacokinetics of CYP3A4 and p-glycoprotein inhibition on lenvatinib: CmaxRandomized · Open-label · TreatmentPhase 1CompletedDrug: ketoconazole-placebo, placebo-ketoconazoleHealthy Volunteers18Jun 2011actual2015-02-13
A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid TumorsNCT00908908results2012-01-27Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: eribulinAdvanced Solid Tumors6May 2011actual2012-03-09
Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)NCT01192113Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to BaselineRandomized · Open-label · TreatmentPhase 4CompletedDrug: Mecobalamin IV Injection, Mecobalamin IM injection, Mecobalamin IV or IM injectionPeripheral Neuropathy1,072May 2011actual2012-11-07
An Study of Efficacy and Safety of ClevudineNCT01192854Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Clevudine, AdefovirChronic Hepatitis B288May 2011actual2013-05-14
A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult MalesNCT01506739PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.Randomized · Open-labelPhase 1CompletedDrug: Donepezil Hydrochloride, Donepezil Hydrochloride, Donepezil HydrochlorideHealthy Adult12May 2011actual2012-01-10
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy SubjectsNCT01327872Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditionsRandomized · Open-label · TreatmentPhase 1CompletedDrug: E5501 40 mg 2 x 20-mg tablets, orally, fasted, E5501 40 mg 2 x 20-mg tablets, orally, with food, E5501 40mg 2 x 20-mg tablets, orally, fasted, E5501 40 mg 2 x 20-mg tablets, orally, with foodPurpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia84Apr 2011actual2012-03-09
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With PerampanelNCT01531920Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel aloneRandomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: alcohol + placebo, alcohol + perampanel, perampanel + alcohol, placebo + alcoholCentral Nervous System59Apr 2011actual2012-02-13
Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by HistologyNCT00784303results2019-08-01Objective Response Rate (ORR)Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: Lenvatinib (DTC Cohort), Lenvatinib (MTC Cohort)Thyroid Cancer1172011-04-11actual2020-04-22
Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung CancerNCT01104155results2017-02-14Objective Response Rate (ORR)Randomized · Open-label · TreatmentPhase 2CompletedDrug: eribulin mesylate + erlotinib, eribulin mesylate + erlotinibNon-small Cell Lung Cancer1232011-04-07actual2023-06-22
Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)NCT00566254results2012-12-11Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Zonisamide, PlaceboEpilepsy; Paediatric Partial Onset Seizures207Mar 2011actual2013-05-13
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy BodiesNCT00598650results2014-09-03Change From Baseline in Mini-mental State Examination (MMSE) TotalNon-randomized · Open-label · TreatmentPhase 2CompletedDrug: E2020Dementia With Lewy Bodies (DLB)160Mar 2011actual2014-09-03
E2022 Patch Formulation Single Dose Phase I StudyNCT01253434Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.Randomized · Open-label · TreatmentPhase 1CompletedDrug: E2022, E2022, E2022, E2022, E2022Japanese Healthy Male Adult Volunteers80Mar 2011actual2013-05-14
A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy SubjectsNCT01289509• To evaluate the bioavailability (BA) , as measured by AUC point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference).Randomized · Open-label · TreatmentPhase 1CompletedDrug: E5501, Drug: E5501Idiopathic Thrombocytopenia Purpura42Mar 2011actual2013-11-01
Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy SubjectsNCT01396577Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test),Randomized · Open-label · TreatmentPhase 1CompletedDrug: perampanel, perampanelHealthy54Mar 2011actual2012-05-04
Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy SubjectsNCT01396590Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test)Randomized · Open-label · TreatmentPhase 1CompletedDrug: Perampanel, PerampanelHealthy54Mar 2011actual2012-05-04
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable EmulsionNCT01260142results2017-01-27Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))Randomized · Open-label · TreatmentPhase 4CompletedDrug: Fospropofol disodium, propofol, Fospropofol disodium, propofol, Fospropofol disodium, propofolAnesthesia36Feb 2011actual2017-01-27
A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)NCT01306318Oral bioavailabilities: Maximum Concentration (Cmax) of eperisone and diclofenac fixed dose capsules versus eperisone & diclofenac tabletsRandomized · Open-label · TreatmentNot applicableCompletedDrug: eperisone hydrochloride plus diclofenac sodium capsule, eperisone hydrochloride tablet and diclofenac sodium tabletHealthy Volunteers24Feb 2011actual2015-11-17
To Assess the Effect of Rifampicin on the Pharmacokinetics of Eribulin Mesylate in Participants With Advanced Solid TumorsNCT03002493Best overall tumor responseOpen-label · TreatmentPhase 1CompletedDrug: Eribulin mesylate, Eribulin mesylate, RifampicinTumor14Feb 2011actual2017-03-15
Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid TumorsNCT01127178results2024-10-10Maximum Tolerated Dose (MTD) for E7016 in Combination With TemozolomideOpen-label · TreatmentPhase 1Terminatedsponsor's stated reason: Strategic decision, which is unrelated to safetyDrug: E7016 + TMZSolid Tumors122011-02-24actual2024-10-10
FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal CancerNCT01133990results2023-11-07Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)Randomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: The study was terminated early as the combination of E7820 and FOLFIRI was deemed to be not tolerable, hence no efficacy analysis was conducted.Drug: FOLFIRI, E7820, BevacizumabColorectal Cancer52011-02-18actual2023-11-07
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe SepsisNCT00334828All-cause mortality at Day 28.Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: eritoran tetrasodium, PlaceboSevere Sepsis2,000Jan 2011actual2017-07-25
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.NCT01011283results2013-09-18Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.Randomized · Open-label · TreatmentPhase 4Terminatedsponsor's stated reason: The study was stopped due to insufficient enrollment.Drug: decitabine, azacitidineMyelodysplastic Syndromes26Jan 2011actual2014-10-29
Single and Multiple Dose Asian Bridging StudyNCT01251731• To compare the single-dose pharmacokinetics (PK), as measured by AUCinf of three doses of E5501 (10, 40, and 80 mg) in healthy Japanese and Chinese subjects relative to healthy Caucasian subjectsRandomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: E5501, E5501, E5501, E5501Healthy Subjects36Jan 2011actual2012-04-06
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial EpilepsyNCT00477295results2013-02-08Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance PhaseRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Zonisamide, CarbamazepineEpilepsy583Dec 2010actual2015-12-24
To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial SeizuresNCT00699582results2012-11-22Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: E2007 (perampanel), E2007 (perampanel), PlaceboRefractory Partial Seizures389Dec 2010actual2014-07-11
Study of E7389 for Advanced or Metastatic Breast CancerNCT00965523results2013-08-15Number of Subjects With Adverse Events.Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: Eribulin MesylateBreast Cancer81Dec 2010actual2013-08-15
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)NCT01202071results2012-11-27Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 AdministrationRandomized · Open-label · TreatmentPhase 2CompletedDrug: Rabeprazole sodium, 5 mg Tablets, Rabeprazole sodium, 10 mg Tablets, Rabeprazole sodium, 20 mg Tablets, Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)Healthy24Dec 2010actual2012-11-30
A Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy SubjectsNCT01261156Evaluate the effects of diltiazem on the pharmacokinetics (PK ie. Cmax, Tmax, AUC and half-life) of E5555 and its known metabolites.Randomized · Open-label · TreatmentPhase 1CompletedDrug: E5555 100 mg and diltiazem, E5555 300 mg and diltiazemHealthy Subjects24Dec 2010actual2014-07-11
Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy VolunteersNCT02533102E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration)Randomized · Open-label · TreatmentPhase 1CompletedDrug: E7050Healthy Subjects42Dec 2010actual2015-11-20
A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis VulgarisNCT01268527results2021-06-11Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic InfiltrateRandomized · TreatmentPhase 2CompletedDrug: 0.03% E6201, 0.1% E6201, 0.2% E6201, 0.005% E6201, 0.01% E6201, 0.05% E6201, Calcipotriene · Other: Placebo - 0.03% gel vehicle, Placebo - 0.1% gel vehicle, Placebo - 0.2% gel vehicle, Placebo - 0.05% gel vehicle, Placebo - 0.01% gel vehicle, Placebo - 0.05% gel vehiclePsoriasis Vulgaris302010-12-11actual2021-06-11
A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)NCT01054456results2020-12-23Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1Open-label · PreventionPhase 2CompletedDrug: palonesetronPatients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC362010-12-08actual2020-12-23
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain CancerNCT00525590results2020-03-16Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12Open-label · TreatmentPhase 2CompletedDrug: GLIADELMetastatic Brain Cancer692010-12-01actual2020-03-16
A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial SeizuresNCT01546688results2013-02-06Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance PeriodRandomized · Quadruple-masked · TreatmentPhase 4TerminatedDrug: Zonisamide at targeted daily doses of 100-500 mg/day, Placebo administered to match targeted daily doses of 100-500 mg/dayEpilepsy41Nov 2010actual2016-01-08
A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female SubjectsNCT01209858Part A: Pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LN)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: Perampanel and Microgynon-30, Perampanel and Microgynon-30Partial Onset Epilepsy48Oct 2010actual2013-05-17
Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial SeizuresNCT00699972results2013-02-05Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: E2007 (perampanel), E2007 (perampanel), PlaceboRefractory Partial Seizures3902010-10-19actual2020-01-10
QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid TumorsNCT01106248results2012-04-13Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.Randomized · Open-label · TreatmentPhase 1CompletedDrug: Eribulin MesylateAdvanced Solid Tumor26Sep 2010actual2012-04-13
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy SubjectsNCT01240187To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.Randomized · Open-label · TreatmentPhase 1CompletedDrug: perampanel, perampanelPartial Onset Epilepsy22Sep 2010actual2013-05-14
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg TabletsNCT01153659Percentage of time that intragastric pH remains >4Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E3810, Aciphex (rabeprazole), Nexium (esomeprazole)Healthy90Aug 2010actual2013-11-01
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes MellitusNCT00603291results2013-02-07Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID), Matching PlaceboObesity604Jun 2010actual2019-10-02
A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy SubjectsNCT01260155To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.Randomized · Open-label · TreatmentPhase 1CompletedDrug: E5501, E5501, E5501Healthy Subjects16Jun 2010actual2013-11-01
A Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients With Advanced Solid Tumors or Lymphomas, Who Are Unsuitable For, or Have Failed, Existing Therapies.NCT02578316results2017-06-20Maximum Plasma Concentration (Cmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled LenvatinibOpen-label · TreatmentPhase 1CompletedDrug: LenvatinibAdvanced Solid Tumors, Lymphomas6Jun 2010actual2017-06-20
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)NCT00770510results2013-02-04Latency To Persistent Sleep (LPS)Randomized · Double-masked · TreatmentPhase 2/3CompletedDrug: Eszopiclone 1 mg, Eszopiclone 2 mg, Eszopiclone 3 mg, Placebo, Zolpidem Tartrate 10 mgPrimary Insomnia192May 2010actual2013-02-04
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)NCT00770692results2012-11-22Incidence of Adverse EventsRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, Eszopiclone 3 mg- Non-elderly, Eszopiclone 2 mg- Non-elderlyInsomnia369May 2010actual2012-11-22
Study of E3810 for Healthy Japanese Male (Under Fasting Condition)NCT01085695The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: rabeprazole, rabeprazole, rabeprazole, rabeprazoleHealthy16May 2010actual2013-05-13
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)NCT01085708The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: rabeprazole, rabeprazole, rabeprazole, rabeprazoleHealthy16May 2010actual2013-05-13
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial SeizuresNCT00448539results2012-12-10Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline PhaseNon-randomized · Open-label · TreatmentPhase 3Terminatedsponsor's stated reason: The study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide.Drug: RufinamideRefractory Partial Onset Seizures2862010-05-14actual2019-11-22
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's DiseaseNCT00566501results2012-06-19Number of Participants With Adverse Events (AEs)Non-randomized · Open-label · TreatmentPhase 3CompletedDrug: DonepezilAlzheimer's Disease9152010-04-01actual2021-11-17
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.NCT01063556Pharmacokinetics parameter: maximum drug concentration in plasmaRandomized · Open-label · TreatmentPhase 4CompletedDrug: donepezil HCl, donepezil HClEnd-Stage Renal Disease6Mar 2010actual2013-05-14
A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)NCT00543855results2013-02-18Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)Randomized · Double-masked · TreatmentPhase 2CompletedDrug: 3 mg Donepezil hydrochloride, 5 mg Donepezil hydrochloride, 10 mg Donepezil hydrochloride, PlaceboDementia With Lewy Bodies (DLB)167Feb 2010actual2013-03-08
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)NCT01055834results2013-02-12Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)Randomized · Open-label · TreatmentPhase 1CompletedDrug: Eszopiclone 3 mg, Eszopiclone 1 mgInsomnia42Feb 2010actual2013-02-12
Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)NCT00967499results2021-01-11Percentage of Participants With Complete ControlRandomized · Open-label · TreatmentPhase 2CompletedDrug: Ondansetron, PalonosetronPostoperative Nausea and Vomiting2392009-12-18actual2021-01-11
A Phase II Study of the Safety and Efficacy of E7820 Plus Cetuximab in Colorectal Cancer, Preceded by a Run-in Study in Advanced Solid TumorsNCT00309179Objective tumor response (CR or PR) and disease control (CR, PR or SD) rates will be evaluated in this study based on RECIST criteria and modified WHO criteria.Open-label · TreatmentPhase 2CompletedDrug: E7820 plus cetuximabAdvanced Colorectal Cancer412009-12-14actual2017-09-14
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)NCT00592904results2013-02-08Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.Open-label · TreatmentPhase 2/3CompletedDrug: E2007Neuralgia262Nov 2009actual2016-01-21
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux EsophagitisNCT00770913results2012-04-13Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)Randomized · Double-masked · TreatmentPhase 2/3CompletedDrug: E3810, E3810, E3810Refractory Reflux Esophagitis337Nov 2009actual2012-04-18
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)NCT00849212results2013-02-07Maximum Tolerated Dose (MTD)Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: E2007Refractory Partial Seizures30Nov 2009actual2013-02-07
An Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid MalignanciesNCT00121732Determine the maximum tolerated dose of E7974 in patients with solid malignancies.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7974, E7974Solid Tumor Malignancies, Cancer39Oct 2009actual2015-07-01
Trial of Decitabine in Patients With Acute Myeloid LeukemiaNCT00260832results2011-09-21Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.Randomized · Open-label · TreatmentPhase 3CompletedDrug: Cytarabine or Supportive Care, Dacogen (decitabine) onlyAcute Myeloid Leukemia485Oct 2009actual2019-09-11
Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular DementiaNCT00165763Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus).Non-randomized · Open-label · TreatmentPhase 4CompletedDrug: donepezil hydrochloride (Aricept)Vascular Dementia36Sep 2009actual2012-05-04
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary SyndromeNCT00619164Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: E5555, E5555, E5555, PlaceboAcute Coronary Syndrome240Sep 2009actual2013-05-13
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)NCT00658528results2015-06-23Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 WeeksRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Rabeprazole sodium, EsomeprazoleGastroesophageal Reflux Disease (GERD)1,061Sep 2009actual2015-12-21
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)NCT00658775results2015-06-23Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 WeeksRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Rabeprazole sodium, EsomeprazoleGastroesophageal Reflux Disease (GERD)1,069Sep 2009actual2015-12-21
ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic DrugsNCT00659958Frequency of seizures.Non-randomized · Open-label · TreatmentPhase 4CompletedDrug: ZonisamideEpilepsy32Sep 2009actual2013-05-13
Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh SystemNCT00706095results2012-01-30Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7389, E7389, E7389Cancer18Sep 2009actual2012-03-27
To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food IntakeNCT00829140To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment.Randomized · Double-maskedPhase 1CompletedDrug: Placebo, Lorcaserin 10mg BIDObesity56Sep 2009actual2019-09-12
A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid MalignanciesNCT00130169Determine the maximum tolerated dose of E7974 in patients with solid malignancies.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7974Cancer, Malignant Tumors30Aug 2009actual2015-07-01
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized SeizuresNCT00292461results2011-08-15The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From BaselineRandomized · Open-label · TreatmentPhase 3CompletedDrug: Zonisamide, LamotrigineEpilepsy64Aug 2009actual2013-05-20
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial SeizuresNCT00700310results2012-11-22Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: perampanel, perampanel, perampanel, PlaceboRefractory Partial Seizures712Aug 2009actual2016-01-21
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)NCT00839306results2015-11-16Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Rabeprazole ER, RanitidineGastroesophageal Reflux Disease (GERD)240Aug 2009actual2016-02-08
Evaluating the Pharmacokinetics and Tolerance of Co-administration of Oral Multiple Dose of Ketoconazole and an IV (Bolus) Infusion of Eribulin in Patients With Advanced Solid TumorsNCT01000376results2013-09-23Mean (SD) Maximum Observed Concentration (Cmax) of EribulinNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: Eribulin alone, Eribulin plus KetoconazoleCancer12Aug 2009actual2013-09-23
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity ManagementNCT00603902results2013-02-07Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID), Matching PlaceboObesity4,008Jul 2009actual2019-10-04
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)NCT00838526results2015-06-23Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Rabeprazole ER, RanitidineGastroesophageal Reflux Disease (GERD)2402009-07-31actual2022-04-25
Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)NCT00911534results2016-02-02Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4Randomized · Double-masked · TreatmentPhase 3CompletedDrug: rabeprazole sodium, PlaceboSymptomatic Gastroesophageal Reflux Disease (sGERD)305Jul 2009actual2016-02-02
A Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid TumoursNCT00459823To determine MTD of E7107. Safety and tolerability.Non-randomized · Open-label · TreatmentPhase 1SuspendedDrug: E7107Cancer40Jun 20092009-03-24
Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's DiseaseNCT00478205results2013-02-05Change From Baseline to Week 24 in SIB Total ScoreRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Aricept (donepezil SR 23 mg), Aricept (donepezil IR 10 mg)Alzheimer's Disease1,467Jun 2009actual2014-07-11
A Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid TumorsNCT00499499Tumor assessments should be performed at screening and then every 2 cycles. A best response according to RECIST (Response Evaluation Criteria in Solid Tumors) will be documented by the investigator for each patient.Non-randomized · Open-label · TreatmentPhase 1SuspendedDrug: E7107Cancer40Jun 20092009-02-04
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003NCT00625443results2018-03-16Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Triple-masked · TreatmentPhase 2CompletedDrug: Blinded (placebo), Open Label (Avatrombopag tablets), Blinded (Avatrombopoag tablets)Idiopathic Thrombocytopenic Purpura53Jun 2009actual2018-03-16
Evaluating The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's DiseaseNCT00711204CSDD (Cornell Scale for Depression in Dementia).Randomized · Double-masked · TreatmentPhase 4Withdrawnsponsor's stated reason: No patients were enrolled in the study.Drug: Donepezil Hydrochloride (Aricept)Severe Alzheimer's Disease0Jun 2009actual2012-12-10
An Open Label Dose Escalation Study Of E7080NCT00121719results2016-05-27Maximum Tolerated Dose (MTD)Open-label · TreatmentPhase 1CompletedDrug: LenvatinibSolid Tumor or Lymphoma822009-06-19actual2023-06-22
A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine CervixNCT00264732Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period.Randomized · Triple-masked · TreatmentPhase 2/3CompletedDrug: Amolimogene, Amolimogene · Other: PlaceboUterine Cervical Dysplasia251May 2009actual2013-05-29
E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast CancerNCT00388726results2012-01-30Overall SurvivalRandomized · Open-label · TreatmentPhase 3CompletedDrug: E7389, Physician's ChoiceBreast Cancer762May 2009actual2020-01-07
Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer TreatmentNCT00688376results2020-03-27Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) "D-prime" Standard Score (SS) at Week 12Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Donepezil hydrochloride, PlaceboAttention Impairment722009-05-26actual2022-01-05
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial SeizuresNCT00334958results2013-02-05Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline PhaseRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Placebo, RufinamideEpilepsy3562009-05-20actual2021-06-14
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary SyndromeNCT00548587Safety and tolerabilityRandomized · Double-masked · TreatmentPhase 2CompletedDrug: E5555, PlaceboAcute Coronary Syndrome600Apr 2009actual2016-02-04
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)NCT00658632results2015-06-23Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 WeeksRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Rabeprazole sodium, EsomeprazoleGastroesophageal Reflux Disease (GERD)1,397Apr 2009actual2016-05-04
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug UsersNCT00828659To evaluate the abuse potential of lorcaserinRandomized · Double-masked · OtherPhase 1CompletedDrug: Placebo, Active Comparator #1, Active Comparator #2, Active Comparator #3, Lorcaserin Dose #1, Lorcaserin Dose #2, Lorcaserin Dose #3Drug Abuse, Healthy35Apr 2009actual2019-09-12
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery DiseaseNCT00540670Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECGRandomized · Double-masked · TreatmentPhase 2CompletedDrug: E5555 50 mg, E5555 100 mg, E5555 200 mg, PlaceboCoronary Artery Disease240Mar 2009actual2013-05-13
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity ManagementNCT00395135results2013-02-07Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Lorcaserin 10 mg BID, Matching Placebo BIDObesity3,182Feb 2009actual2019-10-02
Pharmacokinetic Properties of Lorcaserin in Subjects With Renal ImpairmentNCT00828438The primary objective of this study is to assess the pharmacokinetic properties of lorcaserin in subjects with mild, moderate or severe renal impairment as compared to subjects with normal renal function.Open-label · OtherPhase 1CompletedDrug: Lorcaserin 10mgRenal Impairment40Feb 2009actual2019-09-12
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)NCT00441090results2018-01-04Responder Rate (RR) to Avatrombopag on Day 28Randomized · Triple-masked · TreatmentPhase 2CompletedDrug: Placebo, Avatrombopag tabletsChronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic64Jan 2009actual2018-03-07
The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living FacilityNCT00571064results2018-03-12Mini Mental State Examination (MMSE) Total Scores by VisitOpen-label · TreatmentPhase 4CompletedDrug: Donepezil HClMild to Severe Alzheimer's Disease97Dec 2008actual2018-09-27
Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)NCT00592774results2013-02-15Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)Randomized · Double-masked · TreatmentPhase 2CompletedDrug: E2007 (perampanel), PlaceboNeuralgia146Dec 2008actual2013-02-15
Comparing The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium ValproateNCT00713622Percent change from Baseline in 28-day seizure frequency at Week 12; response rate at 12 weeks.Randomized · Open-label · TreatmentPhase 4CompletedDrug: Zonisamide, Sodium valproateEpilepsy2Dec 2008actual2015-11-03
Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly SubjectsNCT00828581To compare the single-dose pharmacokinetic (PK) parameters of lorcaserin in the obese or overweight Elderly (> 65) to those obtained from the obese or overweight Adult (18-65)Open-label · OtherPhase 1CompletedDrug: lorcaserinObesity24Dec 2008actual2023-06-18
Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted StateNCT00828724To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted stateOpen-label · OtherPhase 1CompletedDrug: Lorcaserin 10mgObesity24Dec 2008actual2019-09-12
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic ImpairmentNCT00828932The primary objective of this study is to evaluate the pharmacokinetic properties of lorcaserin in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function.Open-label · OtherPhase 1CompletedDrug: LorcaserinHepatic Impairment24Dec 2008actual2019-09-12
Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTNCT00566462results2012-12-24Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4Randomized · Double-masked · TreatmentPhase 2Terminatedsponsor's stated reason: Study stopped due to lack of efficacy.Drug: perampanel, placeboParkinson's Disease12008-12-01actual2018-09-06
Adjunctive Zonisamide in Primary Generalised Tonic Clonic SeizuresNCT00692003results2012-10-12Number of Participants Considered Responders as Assessed During the Maintenance PeriodRandomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Sponsor's decisionDrug: Zonisamide, PlaceboEpilepsy21Nov 2008actual2017-03-14
Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised EpilepsyNCT00693017results2012-09-12Number of Participants Considered Responders as Assessed During the Maintenance PeriodRandomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Sponsor's decisionDrug: Zonisamide, PlaceboEpilepsy10Nov 2008actual2015-12-24
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17NCT00754052results2018-04-23Mean Change From Baseline in Vineland-II Adaptive Behavior Scale (VABS-II) Parent/Caregiver Rating Form (PCRF) Score Using Last Observation Carried Forward (LOCF)Randomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.Drug: Aricept (donepezil hydrochloride), Aricept (donepezil hydrochloride), PlaceboDown Syndrome, Cognitive Dysfunction8Nov 2008actual2018-04-23
A Study of Eritoran (E5564) Administered IV Over 14 Days Prior to and During Bone Marrow Engraftment in BMT Patients Who Have Received Myeloablative Conditioning Treatment and Are Receiving Bone Marrow or Stem Cells From Matched Related DonorsNCT00756912Safety and assessments will be done daily.Non-randomized · Open-label · PreventionPhase 1Terminatedsponsor's stated reason: This study was terminated in November 2008 due to "a business decision (resources)".Drug: E5564Leukemia30Nov 2008actual2014-07-11
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled TrialNCT00675025results2021-03-29Change From Visit 1 (Baseline) to Visit 4 or Early Termination in the Vineland Adaptive Behavior Scales, 2nd Edition, Parent/Caregiver Rating Form (VABS-II/PCRF) Sum of the 9 Sub-domain V-scoresOpen-label · TreatmentPhase 2Terminatedsponsor's stated reason: Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.Drug: Donepezil hydrochloride (Aricept)Down Syndrome1172008-11-13actual2021-03-29
A Clinical Trial of Decitabine in Patients With Myelodysplastic SyndromeNCT00282399Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.Randomized · Open-label · TreatmentPhase 1TerminatedDrug: Subcutaneous DecitabineMyelodysplastic Syndrome41Oct 2008actual2015-10-28
A Study of ZYC300 Administered With Cyclophosphamide Pre-DosingNCT00381173Determine the feasibility, safety and tolerability of administering ZYC300 intramuscularly every other wk for 6 doses (400 micrograms DNA/total dose) to the study pop. pre-dosed with 600 mg/m^2 cyclophosphamide intravenously 3 days prior to study drug.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)Breast Cancer, Ovarian Cancer, Prostate Cancer, Colon Cancer, Renal Cancer22Oct 2008actual2013-05-14
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10NCT00754013results2013-02-13Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.Randomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Sufficient evidence of efficacy not met.Drug: Aricept (Donepezil hydrochloride), PlaceboDown Syndrome, Cognitive Dysfunction9Oct 2008actual2020-01-28
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential HypertensionNCT00130156Blood PressureRandomized · Open-label · TreatmentPhase 4CompletedDrug: Bunazosin, Doxazosin, ValsartinHigh Blood Pressure93Sep 2008actual2013-05-14
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid TumorsNCT00280397results2015-03-06Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a DayOpen-label · TreatmentPhase 1CompletedDrug: E7080Cancer: Solid Tumors27Sep 2008actual2016-10-07
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down SyndromeNCT00570128results2021-04-19Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-Domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 10-Last Observation Carried Forward (LOCF)Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Donepezil HCl, PlaceboDown Syndrome1292008-09-05actual2021-04-19
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell LymphomaNCT00211185results2020-03-18Summary of All Adverse Events by Frequency in Greater Than 20% of Treated ParticipantsOpen-label · TreatmentPhase 2CompletedDrug: Denileukin diftitox, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone · Other: PegfilgrastimLymphoma, T-Cell, Peripheral49Aug 2008actual2020-03-18
Neural Correlates In Mild Alzheimer's DiseaseNCT00477659results2021-11-10Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI)Open-label · TreatmentPhase 4CompletedDrug: Donepezil hydrochlorideAlzheimer's Disease142008-08-15actual2021-11-10
An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic NeuropathyNCT00505284results2013-02-08Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)Randomized · Double-masked · TreatmentPhase 2/3CompletedDrug: Placebo, E2007 (2 mg), E2007 (4 mg), E2007 (6 mg), E2007 (8 mg)Diabetic Neuropathy352Jul 2008actual2014-07-11
Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet ChemotherapyNCT00100932results2012-01-31Overall Objective Response Rate (ORR)Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: E7389 28 Day Cycle, E7389 21 Day CycleNon-Small-Cell Lung Carcinoma106Jun 2008actual2012-03-27
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic SyndromesNCT00260065results2009-09-04Number of Participants Who Achieved Overall ResponseNon-randomized · Open-label · TreatmentPhase 2CompletedDrug: DecitabineMyelodysplastic Syndrome99Jun 2008actual2013-05-20
Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type PsoriasisNCT00539929Total Symptom Severity (TSS) at week 8.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: E6201 0.005%, E6201 0.01%, E6201 0.03%, PlaceboChronic Plaque Psoriasis100Jun 2008actual2017-02-06
Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor FluctuationsNCT01634360results2013-02-05Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension StudyOpen-label · TreatmentPhase 2Terminatedsponsor's stated reason: Due to termination of clinical program for Parkinson's DiseaseDrug: PerampanelParkinson's Disease185Jun 2008actual2014-07-09
Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial SeizuresNCT00327717results2014-08-15Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose PhaseRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Zonisamide, PlaceboPartial Seizures240May 2008actual2014-08-15
Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsNCT00360308results2012-11-22Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 18 (Including LOCF Data)Randomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Study stopped due to lack of efficacy.Drug: Placebo, E2007, E2007Parkinson's Disease723Apr 2008actual2014-07-11
A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsNCT00360412results2013-02-05Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension StudyNon-randomized · Open-label · TreatmentPhase 3Terminatedsponsor's stated reason: Study stopped due to lack of efficacy.Drug: E2007Parkinson's Disease997Apr 2008actual2014-07-11
A Study of E2007 In Patients With Parkinson's DiseaseNCT00427011results2013-02-05Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension StudyNon-randomized · Open-label · TreatmentPhase 2Terminatedsponsor's stated reason: Study stopped due to lack of efficacy.Drug: E2007Parkinson's Disease25Apr 2008actual2013-02-11
Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsNCT00505622results2012-11-22Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension StudyOpen-label · TreatmentPhase 3Terminatedsponsor's stated reason: Study stopped due to lack of efficacy.Drug: PerampanelParkinson's Disease328Apr 2008actual2016-01-21
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary EmbolismNCT00442234Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).Non-randomized · Open-label · TreatmentPhase 4CompletedDrug: MonteplasePulmonary Embolism52008-04-01actual2018-10-18
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery DiseaseNCT00312052Safety and tolerability - especially the risk of bleedingRandomized · Double-masked · TreatmentPhase 2CompletedDrug: E5555, PlaceboCoronary Artery Disease720Mar 2008actual2016-12-05
Hippocampus Study: Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological MarkersNCT00403520Evolution of the volume of the Hippocampi, measured by magnetic resonance imaging (MRI), between D0 and final visit (12 months ).Randomized · Double-masked · TreatmentPhase 4CompletedDrug: Experimental 1, Placebo ComparatorAlzheimer's Disease240Mar 2008actual2014-07-14
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)NCT00358644results2009-09-07Complete Response = Morphologic Complete Remission (mCR)Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: DecitabineAcute Myeloid Leukemia55Feb 2008actual2013-05-20
Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial SeizuresNCT00416195results2012-11-22Percentage of Responders During the Maintenance PhaseRandomized · Double-masked · TreatmentPhase 2CompletedDrug: E2007, PlaceboEpilepsy48Feb 2008actual2014-07-11
Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior ChemotherapyNCT00278993results2012-05-15Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley CriteriaNon-randomized · Open-label · TreatmentPhase 2CompletedDrug: E7389Prostate Cancer108Jan 2008actual2014-07-14
Phase I Clinical Study of E7389NCT00326950results2011-12-20Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7389Cancer15Jan 2008actual2012-03-08
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsNCT00368108results2013-02-05Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: 2 mg perampanel, 4 mg perampanel, placebo comparatorParkinson's Disease752Jan 2008actual2013-05-20
A Phase I Open Label Study of E7974 Administered on a Day 1 of 21-Day Cycle In Patients With Advanced Solid TumorsNCT00165802Determine the maximum tolerated dose of E7974 in patients with Advanced Solid Tumors.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7974Cancer, Malignant Tumors40Dec 2007actual2013-05-22
Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.NCT00306735Randomized · Triple-masked · TreatmentPhase 2CompletedDrug: PalonosetronMultiple Myeloma75Dec 2007actual2016-12-05
A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and CapecitabineNCT00246090results2012-05-15Objective Response RateNon-randomized · Open-label · TreatmentPhase 2CompletedDrug: E7389Breast Cancer298Sep 2007actual2014-07-14
A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive ImpairmentNCT00934375results2009-07-08Number of Participants With Treatment-Emergent Adverse EventsRandomized · Open-label · TreatmentPhase 4CompletedDrug: Aricept (donepezil hydrochloride), placeboMild Cognitive Impairment145Sep 2007actual2014-01-14
Open Label, Zonegran (Zonisamide) In Partial Onset SeizuresNCT00215592Seizure frequency, compared to baseline.Non-randomized · Open-label · TreatmentPhase 4CompletedDrug: ZonegranEpilepsy1,000Jul 2007actual2016-01-08
The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsNCT00286897Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).Randomized · Double-masked · TreatmentPhase 3CompletedDrug: E2007Parkinson's Disease702Jun 2007actual2015-11-03
EARTH 413: A Study of Aricept in Hispanic Patients With Mild to Moderate Alzheimer's Disease (AD)NCT00230568FOME (Fuld Object Memory Evaluation); SDMT (Symbol Digit Modalities Test); NPI (Neuropsychiatric Inventory); MMSE (the Mini-Mental State Examination).Non-randomized · Open-label · TreatmentPhase 4CompletedDrug: AriceptAlzheimer's Disease100Apr 2007actual2011-04-01
Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid TumorsNCT00374660Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria.Non-randomized · Open-label · TreatmentPhase 1/2CompletedDrug: Oxaliplatin, IrofulvenLiver Cancer63Apr 2007actual2021-12-08
A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole SodiumNCT00125736Ratio of S2-stage transition at 8 weeks after the study administration.Randomized · Double-masked · TreatmentPhase 4CompletedDrug: E0671, rabeprazole sodium, E0671 placeboStomach Ulcer5202007-04-19actual2018-10-29
A Comparative Study of KES524 in Patients With Obesity DiseaseNCT00165685Change and percent change in body weightRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Sibutramine Hydrochloride MonohydrateObesityMar 2007actual2010-01-29
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)NCT00293176Assessment of cognitive and global function in subjects with MCI.Randomized · Double-masked · TreatmentPhase 4CompletedDrug: Donepezil Hydrochloride, PlaceboMemory Loss821Mar 2007actual2011-04-01
E2007 Given as Adjunctive Therapy in Patients With Refractory Partial SeizuresNCT00144690To determine the maximum tolerated dose (MTD) of E2007 given bid or qd in patients with refractory partial-onset seizures (including secondarily generalized seizures)Randomized · Double-masked · TreatmentPhase 2CompletedDrug: E2007 (perampanel), PlaceboEpilepsyFeb 2007actual2015-11-03
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis WomenNCT00165698results2011-08-11Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 MonthsRandomized · Double-masked · TreatmentPhase 3CompletedDrug: menatetranone, alfacalcidolPostmenopausal Osteoporosis240Jan 2007actual2014-07-22
A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's LymphomaNCT00211276Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.Non-randomized · Open-label · TreatmentPhase 2CompletedDrug: ONTAK (denileukin diftitox)Lymphoma, B-Cell50Jan 2007actual2012-03-14
A Study of E7389 in Advanced/Metastatic Breast Cancer PatientsNCT00097721results2013-03-15Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)Open-label · TreatmentPhase 2CompletedDrug: E7389Breast Neoplasms104Nov 2006actual2013-04-22
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma PatientsNCT00051012Objective Rate of Response (ORR), defined as CR + CCR + PRNon-randomized · Open-label · TreatmentPhase 4CompletedDrug: ONTAKLymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome86Oct 2006actual2008-03-05
The Efficacy, Safety, And Tolerability Of Donepezil HCl (E2020) In Patients With CADASIL Who Have Cognitive ImpairmentNCT00103948Cognitive function.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: AriceptCognitive Impairment165Oct 2006actual2015-11-03
Study Investigating the Effect of E7337 on Tumor Like Lesions in Computed Tomography (CT) of the LiverNCT00280410Contrast enhancement effect on tumor-like lesions in the liver.Randomized · Open-label · DiagnosticPhase 2/3CompletedDrug: E7337Lesions of the Liver192Oct 2006actual2010-01-29
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) PatientsNCT00050999Objective Rate of Response (ORR), defined as CR + CCR + PRRandomized · Double-masked · TreatmentPhase 4CompletedDrug: ONTAKLymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome195Sep 2006actual2008-03-05
Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or LymphomaNCT00078637Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: E7820Neoplasms, Lymphoma, Malignant37Aug 2006actual2014-12-23
Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid CancerNCT00124527To determine the objective tumor response rate in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer treated with irofulven/capecitabine combination therapyNon-randomized · Open-label · TreatmentPhase 2CompletedDrug: Irofulven + capecitabineThyroid Cancer352006-08-31actual2021-06-16
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian SubjectsNCT00280384results2013-04-25Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From BaselineRandomized · Single-masked · TreatmentPhase 2CompletedDrug: E2014 (Botulinum toxin type B), E2014 (Botulinum toxin type B) PlaceboSpasmodic Torticollis48Aug 2006actual2013-04-25
A Study of E7070 in Patients With Gastric CancerNCT00165594Phase I study:Non-randomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Study was completed.Drug: E7070Gastric Cancer50Jul 2006actual2014-01-23
Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With DementiaNCT01327859Safety and tolerability will primarily be assessed by recording of AEsNon-randomized · Open-label · TreatmentPhase 3CompletedDrug: Prior Donepezil 5mg, Prior Donzepezil 10mg, Prior PlaceboParkinson's Disease, Dementia357Jul 2006actual2015-11-03

Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.

Source: ClinicalTrials.gov, retrieved 2026-08-19