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Clinical trials
catalyst calendar across sponsors →Studies where JAZZ 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.
180 interventional · 16 observational · 8 expanded access · 110 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During PregnancyNCT06113237observationalRate of MCM | — | Recruiting | Drug: Epidiolex | Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy | 50 | 2033-08-31 | in 2,569 d | 2026-07-24 |
| A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEENCT07723976Change in Countable Motor Seizure Frequency Per 28 DaysRandomized · Double-masked · Treatment | Phase 3 | Not yet recruiting | Drug: CBD-OS, Placebo | Developmental and Epileptic Encephalopathy (DEE) | 120 | 2029-09-04 | in 1,112 d | 2026-07-24 |
| A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGSNCT07728097Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequencyOpen-label · Treatment | Phase 4 | Not yet recruiting | Drug: Cannabidiol Oral Solution | Lennox-Gastaut Syndrome | 40 | 2028-12-28 | in 862 d | 2026-07-27 |
| Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and ParagangliomaNCT07282587Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: ONC206, ONC206: Dose 1, ONC206: Dose 2 | Advanced Pheochromocytoma and Paraganglioma, PCPG | 90 | 2028-12-15 | in 849 d | 2026-06-10 |
| Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract CancerNCT06282575Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumorsRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Zanidatamab, Cisplatin, Gemcitabine, Pembrolizumab, Durvalumab | Biliary Tract Cancer | 286 | 2028-12-01 | in 835 d | 2026-07-14 |
| A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 MeningiomaNCT07533942Overall Response Rate (ORR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria and Evaluated by Blinded Independent Central Review (BICR)Open-label · Treatment | Phase 2 | Recruiting | Drug: JZP3507 | Meningioma | 30 | 2028-10-25 | in 798 d | 2026-07-30 |
| A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic EpilepsyNCT07723963Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)Randomized · Double-masked · Treatment | Phase 2/3 | Not yet recruiting | Drug: JZP926 capsule, Placebo | Juvenile Myoclonic Epilepsy | 260 | 2028-08-01 | in 713 d | 2026-07-24 |
| ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)NCT05580562Overall survival (OS)Randomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: Dordaviprone (ONC201), Dordaviprone (ONC201) + Placebo · Other: Placebo | H3 K27M, Glioma | 510 | Jun 2028 | ≤ 681 d | 2026-04-16 |
| A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast CancerNCT06435429Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine, Capecitabine | Metastatic HER2-positive Breast Cancer | 550 | 2028-04-28 | in 618 d | 2026-02-10 |
| A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815NCT05557045Number of Participants With Dose-Limiting Toxicities (Part A)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: JZP815 | Advanced Cancer, Metastatic Cancer, Solid Tumor | 332 | 2028-04-01 | in 591 d | 2026-04-23 |
| A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLCNCT07459634Investigator assessed PFS rateOpen-label · Treatment | Phase 2 | Recruiting | Drug: Lurbinectedin, Durvalumab | Extensive-stage Small-cell Lung Cancer | 50 | 2028-01-31 | in 530 d | 2026-07-20 |
| Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing SarcomaNCT05734066Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Lurbinectedin | Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma | 60 | 2028-01-28 | in 527 d | 2026-02-03 |
| A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast CancerNCT07102381Number of participants with pCRRandomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Zanidatamab, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab, Pertuzumab | HER2-positive Breast Cancer, Breast Cancer | 125 | 2028-01-01 | in 500 d | 2026-07-15 |
| A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IHNCT07625280Change in Epworth Sleepiness Scale (ESS) scoresRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Xywav · Other: Placebo | Narcolepsy, Idiopathic Hypersomnia | 120 | 2027-12-23 | in 491 d | 2026-08-19 |
| JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid TumorsNCT06108050Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination TherapyNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: JZP898, Pembrolizumab | Advanced Solid Tumor, Metastatic Solid Tumor | 177 | 2027-11-30 | in 468 d | 2025-12-16 |
| A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset SeizuresNCT07233239Percent change in countable focal seizure frequency compared to baselineOpen-label · Treatment | Phase 1 | Recruiting | Drug: CBD-OS | Focal Seizures | 100 | 2027-11-29 | in 467 d | 2026-08-11 |
| Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionNCT05044819Number of Participants With Liver Fibrosis and Evaluable Fibrotic Changes as Determined and Assessed by an Independent Adjudication CommitteeOpen-label · Treatment | Phase 4 | Active, not recruiting | Drug: Cannabidiol | Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex | 154 | 2027-08-01 | in 347 d | 2026-07-28 |
| Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALYNCT05485831observationalNumber of Participants Remaining on Therapy from Enrollment | — | Active, not recruiting | Drug: Epidiolex 100 mg/mL Oral Solution | Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex | 111 | Feb 2027 | ≤ 193 d | 2026-06-03 |
| A Phase 2 Study of Zanidatamab in Patients With HER2-expressing TumorsNCT06695845Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICRNon-randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Zanidatamab | Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Urothelial Carcinoma, Salivary Gland Cancer, Pancreatic Cancer, HER-2 Protein Overexpression | 200 | 2026-12-31 | in 134 d | 2026-07-10 |
| Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System NeoplasmsNCT04541082Maximum Tolerated Dose (MTD) of single-agent, oral ONC206Open-label · Treatment | Phase 1 | Recruiting | Drug: ONC206 | Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Adult, Anaplastic Oligodendroglioma, Anaplastic Astrocytoma, Pilocytic Astrocytoma, Oligodendroglioma, Gliomatosis Cerebri, Pleomorphic Xanthoastrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, Diffuse Midline Glioma, H3 K27M-Mutant, Ependymoma, Ependymoma, Anaplastic, Medulloblastoma, Teratoid Rhabdoid Tumor, Neuroectodermal Tumors, Primitive, Neuroectodermal Tumors, Anaplastic Meningioma, Atypical Meningioma, Choroid Plexus Neoplasms, Pineal Tumor, Diffuse Astrocytoma, Glial Tumor | 102 | Jul 2026 | — | 2025-12-18 |
| A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal CancersNCT05152147Progression-free survival (PFS) by BICRRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin, Cisplatin, 5-Fluorouracil | Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma | 920 | 2026-07-31 | — | 2026-07-17 |
| Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life SettingNCT05772429observationalRetention Rate Percentage After Initiation of Treatment With Epidyolex | — | Active, not recruiting | Drug: Epidiolex | Seizures | 158 | Jul 2026 | — | 2026-06-15 |
| A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy ParticipantsNCT07377539Number of Participants Reporting Treatment-emergent Adverse Events (Part A)Randomized · Double-masked · Treatment | Phase 1 | Recruiting | Drug: JZP047 · Other: Placebo | Healthy Participants | 86 | 2026-07-05 | — | 2026-04-20 |
| Child and Adolescent Registry for Participants With NarcolepsyNCT04899947observationalImprove Understanding of Natural History of Pediatric Narcolepsy | — | Recruiting | — | Narcolepsy | 500 | 2024-10-01 | — | 2024-08-15 |
| A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis ComplexNCT05864846Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQOpen-label · Treatment | Phase 4 | Completed | Drug: Cannabidiol Oral Solution [Epidiolex] | Tuberous Sclerosis Complex Associated Neuropsychiatric Disease | 79 | 2026-04-06actual | — | 2026-04-27 |
| A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1NCT06961266Mean sleep latency of the first 4 sessions of the Maintenance of Wakefulness TestRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated based on a business decision by the Sponsor. | Drug: JZP441, Matching Placebo | Narcolepsy | 6 | 2026-01-29actual | — | 2026-04-06 |
| VYxeoS Liposomal Italian Observational Study iN the Real PracticeNCT06143839observationalPercentage of participants showing CR/CRi/CRh without MRD at the end of treatment | — | Completed | Drug: Vyxeos liposomal | Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia | 113 | 2025-10-23actual | — | 2025-11-20 |
| A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal CancerNCT03929666Incidence of dose-limiting toxicities (DLTs) (Part 1)Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: ZW25 (Zanidatamab), Capecitabine, Cisplatin, Fluorouracil, Leucovorin, Oxaliplatin, Bevacizumab, Gemcitabine | HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer | 74 | 2025-08-30actual | — | 2025-09-12 |
| A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing CancerNCT05027139Incidence of dose-limiting toxicities (DLTs; Part 1)Open-label · Treatment | Phase 1/2 | Completed | Drug: Zanidatamab, Evorpacept | HER2-expressing Cancers | 52 | 2025-08-29actual | — | 2026-07-01 |
| To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)NCT04894591observationalOverall Response Rate (ORR) | — | Completed | Drug: Zepzelca | Extensive-stage Small-cell Lung Cancer | 272 | 2025-06-04actual | — | 2026-02-27 |
| A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or NarcolepsyNCT05875974Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAVOpen-label · Treatment | Phase 4 | Completed | Drug: JZP258 (XYWAV) | Idiopathic Hypersomnia, Narcolepsy | 207 | 2025-03-13actual | — | 2025-07-17 |
| A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With NarcolepsyNCT05869773results2026-04-24Change From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHgOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: JZP258 | Narcolepsy | 155 | 2025-02-25actual | — | 2026-04-24 |
| Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled SeizuresNCT04485104results2025-10-31Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated by the Sponsor due to low patient enrollment. | Drug: GWP42003-P | Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome | 3 | 2025-01-28actual | — | 2025-10-31 |
| Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing CancersNCT02892123The proportion of patients who experience dose-limiting toxicities (DLTs) (Part 1)Open-label · Treatment | Phase 1 | Completed | Drug: ZW25 (Zanidatamab), Paclitaxel, Capecitabine, Vinorelbine, Tucatinib, Tucatinib | HER2-expressing Cancers | 279 | 2024-10-31actual | — | 2024-11-27 |
| A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's DiseaseNCT05642442results2026-01-15Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome ScoreRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Placebo, Suvecaltamide | Parkinson Disease, Tremor | 169 | 2024-10-23actual | — | 2026-01-15 |
| A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)NCT05122650results2025-07-24Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and PlaceboRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: JZP385 · Other: Placebo | Essential Tremor | 420 | 2024-05-30actual | — | 2025-07-24 |
| A JZP341 Study in Adult Participants With Advanced or Metastatic Solid TumorsNCT05631327Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated based on a business decision by the Sponsor. | Drug: JZP341 | Advanced Solid Tumor, Metastatic Solid Tumor | 12 | 2024-04-24actual | — | 2024-05-28 |
| Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum DisorderNCT04745026results2025-03-30Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total ScoresRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: GWP42003-P, Placebo | Autism Spectrum Disorder | 103 | 2023-12-21actual | — | 2025-03-30 |
| Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid TumorsNCT05126433results2025-02-28Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Termination of this study was a business decision made during portfolio review. | Drug: Lurbinectedin | Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, Homologous Recombination Deficient-Positive Malignancies Agnostic | 47 | 2023-12-20actual | — | 2025-02-28 |
| A Study of JZP150 in Adults With Posttraumatic Stress DisorderNCT05178316results2024-12-31Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity ScoreRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: JZP150, Placebo | Post Traumatic Stress Disorder | 282 | 2023-12-05actual | — | 2024-12-31 |
| A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Healthy ParticipantsNCT05651152Number of Participants With Treatment-emergent Adverse Events After Administration of JZP441 in Sleep-deprived Healthy ParticipantsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: JZP441, Placebo | Healthy Participants | 105 | 2023-11-15actual | — | 2024-07-30 |
| A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum DisorderNCT05733390Mean Change From Baseline to Week 12 in the Aberrant Behavior Checklist-Irritability (ABC-I) Subscale ScoreRandomized · Double-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: A decision has been made to prioritize other pipeline programs and terminate this study. | Drug: JZP541 · Other: Placebo | Irritability Associated With Autism Spectrum Disorder, Autism Spectrum Disorder, ASD | 0 | 2023-11-09actual | — | 2024-11-08 |
| A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy ParticipantsNCT05720494Number of Participants With Treatment-emergent Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: JZP441, Placebo | Healthy Participants | 24 | 2023-09-29actual | — | 2024-10-01 |
| Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic SeizuresNCT05288283results2025-02-03Part A: Percent Change From Baseline in Epilepsy With Myoclonic-atonic Seizures (EMAS) Associated Seizure Frequency (Myoclonic-atonic, Atonic, Tonic, Clonic, or Tonic-clonic) Over the 14-week Treatment PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated due to a business decision. | Drug: GWP42003-P, Placebo | Seizures Associated With EMAS | 3 | 2023-09-28actual | — | 2025-02-03 |
| A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract CancersNCT04466891results2024-08-21Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ZW25 (Zanidatamab) | HER2-amplified Biliary Tract Cancers | 87 | 2023-07-28actual | — | 2025-09-15 |
| A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast CancerNCT04224272results2024-08-14Number of Participants With Dose-Limiting ToxicitiesOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ZW25 (Zanidatamab), Palbociclib, Fulvestrant | HER2+/HR+ Breast Cancer | 51 | 2023-04-28actual | — | 2025-08-01 |
| Oral ONC201 in Adult Recurrent GlioblastomaNCT02525692results2024-12-24Percent of Patients With Probability of Progression-Free Survival at 6 MonthsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: The Sponsor terminated the study to prioritize enrollment in a randomized Phase 3 trial of ONC201 in an earlier setting. This decision was unrelated to any safety concerns with dordaviprone (ONC201). | Drug: Dordaviprone (ONC201) | Glioblastoma, Diffuse Midline Glioma, H3 K27M Glioma, Thalamic Glioma, Infratentorial Glioma, Basal Ganglia Glioma | 84 | 2023-04-17actual | — | 2024-12-24 |
| Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress DisorderNCT04592159Change from Baseline in Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale (Clinician Administered PTSD Scale [CAPS-5]) Score over 8 WeeksRandomized · Triple-masked · Treatment | Phase 2/3 | Withdrawnsponsor's stated reason: The decision to suspend this study was based upon evaluation of pandemic-related challenges impacting both clinical trial sites and potential participants. This suspension was initiated prior to site activation and participant recruitment. | Drug: Nabiximols, Placebo | Post-Traumatic Stress Disorder | 0 | Mar 2023 | — | 2022-06-03 |
| Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple SclerosisNCT04203498results2024-05-08Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized PeriodRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: This study was terminated based on a business decision by the Sponsor. | Drug: Nabiximols, Placebo | Multiple Sclerosis (MS) | 139 | 2023-02-10actual | — | 2024-05-08 |
| ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial CancerNCT03485729results2024-12-24Progression-Free Survival Rate at 2 MonthsNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: This study was terminated due to a change in the Sponsor's corporate priorities. The decision to terminate the study was not based on any safety concerns. | Drug: Dordaviprone (ONC201) | Endometrial Cancer Recurrent | 27 | 2023-01-19actual | — | 2024-12-24 |
| ONC201 in Adults With Recurrent H3 K27M-mutant GliomaNCT03295396results2025-07-28Number of Patients With Overall ResponseNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: The Sponsor terminated the study to prioritize enrollment in a randomized Phase 3 trial of ONC201 in an earlier setting. This decision was unrelated to any safety concerns with dordaviprone (ONC201). | Drug: Dordaviprone (ONC201) | Glioma | 73 | 2022-12-31actual | — | 2025-07-28 |
| ONC201 in Pediatric H3 K27M GliomasNCT03416530RP2DNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The Sponsor terminated the study to prioritize enrollment in a randomized Phase 3 trial of ONC201 in an earlier setting. This decision was unrelated to any safety concerns with dordaviprone (ONC201). | Drug: Dordaviprone (ONC201) | Diffuse Intrinsic Pontine Glioma, Glioma, Malignant | 134 | 2022-12-31actual | — | 2025-02-14 |
| An Interventional Safety Switch Study (Segue Study) of XYWAV in NarcolepsyNCT04794491results2024-01-09Change in Weekly Rate of Cataplexy AttacksOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: JZP-258 | Narcolepsy | 62 | 2022-11-15actual | — | 2024-01-09 |
| Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple SclerosisNCT04984278results2024-02-05Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated based on a business decision by the Sponsor. | Drug: Nabiximols, Placebo | Spasticity With Multiple Sclerosis | 56 | 2022-11-11actual | — | 2024-12-11 |
| An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)NCT04145531results2023-11-18Response Rate During the First Course of JZP-458 AdministrationOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: IM JZP-458, IV JZP-458 | Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia | 229 | 2022-07-13actual | — | 2023-11-18 |
| CPX-351 Real-World Effectiveness and Safety StudyNCT05169307observationalNumber of Participants Achieving Complete Response/Complete Response with Incomplete Platelet or Neutrophil Recovery in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | — | Completed | Drug: CPX-351 | Acute Myeloid Leukemia | 147 | 2022-06-15actual | — | 2022-07-12 |
| Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid LeukemiaNCT04571645results2024-04-15Overall SurvivalRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study enrollment was terminated on 16 May 2022 due to slow recruitment. | Drug: Dociparstat · Other: Control | Acute Myeloid Leukemia | 9 | 2022-05-16actual | — | 2024-04-15 |
| Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple SclerosisNCT04657666results2023-07-20Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Nabiximols, Placebo | Spasticity in Participants With Multiple Sclerosis | 68 | 2022-05-04actual | — | 2023-07-20 |
| A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AMLNCT04038437Maximum Tolerated Dose (MTD) as determined by the specified dose explorationOpen-label · Treatment | Phase 1 | Completed | Drug: CPX-351, Venetoclax | Acute Myeloid Leukemia | 35 | 2022-04-26actual | — | 2022-11-09 |
| Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic TreatmentNCT04421456results2023-06-15Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) ScoreRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: This study was terminated based on a business decision by the Sponsor. | Drug: GWP42003-P, Placebo | Schizophrenia | 95 | 2022-03-16actual | — | 2023-06-15 |
| A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in NarcolepsyNCT04803786observationalNumber of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav | — | Completed | Drug: Transition from Xyrem to Xywav | Narcolepsy | 110 | 2022-02-24actual | — | 2022-06-30 |
| A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid LeukemiaNCT04075747Determine the Recommended Phase 2 Dose (RP2D)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CPX-351, Venetoclax, Midostaurin, Enasidenib | Acute Myeloid Leukemia | 57 | 2022-02-07actual | — | 2023-10-16 |
| Investigation of Cognitive Outcomes With Cannabidiol Oral SolutionNCT04133480Change from Baseline to end of treatment (Day 181 [Visit 5]) in processing speed on the National Institutes of Health Toolbox Cognition Battery (NIHTCB)Open-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: The decision to withdraw the study was based on pandemic-related concerns of conducting a Phase IV study requiring multiple clinic visits when medication is commercially available. The study was withdrawn before any participants were recruited. | Drug: GWP42003-P | Lennox-Gastaut Syndrome | 0 | Dec 2021 | — | 2022-09-01 |
| A Web-based Observational Study of Patient-reported Outcomes in Adults With NarcolepsyNCT02769780observationalDescriptive epidemiology of type 1 and type 2 narcolepsy | — | Completed | — | Narcolepsy | 1,500 | 2021-08-09actual | — | 2022-04-05 |
| An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)NCT02544750results2022-07-14Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: GWP42003-P | Tuberous Sclerosis Complex, Seizures | 199 | 2021-06-11actual | — | 2022-07-14 |
| A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeNCT04252586results2022-08-08Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Discontinuations Due to AEs, Serious AEs, and Treatment-related AEsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study was terminated due to COVID-19 pandemic and recruitment challenges in the parent study (GWND18064 - NCT03848832). | Drug: GWP42003-P | Rett Syndrome, RTT | 21 | 2021-06-09actual | — | 2022-08-08 |
| A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351NCT03555955Pharmacokinetics (PK) of CPX-351Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CPX-351, CPX-351 | Hematologic Malignancy, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes | 21 | 2021-05-26actual | — | 2021-07-22 |
| Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory FailureNCT04389840results2022-08-30Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual. | Drug: Dociparstat sodium, Placebo | Coronavirus Disease 2019 (COVID-19), Acute Lung Injury, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 27 | 2021-05-20actual | — | 2022-08-30 |
| Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeNCT03848832results2021-12-29Change From Baseline in the Mean Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score at Week 24 for the 15 mg/kg/Day GWP42003-P Dose Level Compared With PlaceboRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated due to enrollment challenges and the COVID-19 pandemic. | Drug: GWP42003-P, Placebo | Rett Syndrome, RTT | 29 | 2021-01-21actual | — | 2022-09-02 |
| Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric PatientsNCT02851407results2022-03-02Veno-occlusive Disease (VOD)-Free Survival by Day +30 Post-Hematopoietic Stem Cell Transplant (HSCT) Per the Independent Endpoint Adjudication Committee (EPAC)Randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Defibrotide · Other: Best Supportive Care | Veno-occlusive Disease | 372 | 2020-10-20actual | — | 2022-03-02 |
| A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's DiseaseNCT03436953Change from Baseline to Day 28 on the MDS-UPDRS Tremor Score as scored by the central raterRandomized · Double-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: The program was not initiated nor were any patients ever enrolled. The investigations detailed in the submitted protocol were incorporated into another program. | Drug: CX-8998, Placebo | Parkinson's Disease, Tremor | 0 | Sep 2020 | — | 2021-05-28 |
| A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated NeurotoxicityNCT03954106results2021-12-09Incidence of CAR-T-associated Neurotoxicity of Any Grade, Defined by CTCAE v5.0 by CAR-T Day +30Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Primary endpoint would unlikely to be met based on the unplanned interim assessment on the first 20 efficacy evaluable patients. | Drug: Defibrotide | DLBCL, Neurotoxicity Syndromes | 25 | 2020-09-18actual | — | 2021-12-09 |
| A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety ExtensionNCT03533114results2021-11-24Change in Epworth Sleepiness Scale (ESS) ScoreRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: JZP-258, Placebo Oral Solution | Idiopathic Hypersomnia | 154 | 2020-06-12actual | — | 2021-11-24 |
| Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum DisorderNCT03849456Number of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Study terminated due to enrollment challenges during COVID-19 pandemic. | Drug: GWP42006 | Autism Spectrum Disorder | 1 | 2020-05-26actual | — | 2022-09-02 |
| An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)NCT03339297results2021-08-18Cumulative Incidence Percentage of Grade B to D Acute Graft Versus Host Disease (aGvHD) by Day +100 Post-Hematopoietic Stem Cell Transplant (HSCT)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Defibrotide, Standard of Care | Graft-versus-host Disease, Acute-graft-versus-host Disease | 152 | 2020-05-12actual | — | 2021-08-18 |
| A Post-Marketing Observational Study of VYXEOS™NCT03526926observationalInfusion-Related Reactions on Day 1 | — | Completed | Drug: CPX-351 | Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia | 52 | 2019-10-26actual | — | 2020-08-05 |
| Oral ONC201 in Relapsed/Refractory Multiple MyelomaNCT02863991results2024-07-03Response of Participants at Last On-study Visit (End of Treatment/Follow-up)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: This study was terminated due to a change in corporate priorities. The decision to terminate the study was not based on any safety concerns. | Drug: ONC201, Dexamethasone | Multiple Myeloma | 17 | 2019-09-17actual | — | 2024-07-03 |
| European VOD RegistryNCT03032016observationalIncidence rate of specific SAE of interest | — | Completed | — | Hepatic Veno-Occlusive Disease | 176 | Jul 2019actual | — | 2019-10-16 |
| Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid LeukemiaNCT02873338results2021-10-29Number of Subjects Who Achieved Morphologic Complete RemissionRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Dociparstat sodium, Idarubicin, Cytarabine | Acute Myeloid Leukemia | 75 | Jun 2019actual | — | 2023-09-07 |
| Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)NCT02954887results2020-07-23Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: GWP42003-P | Infantile Spasms | 9 | 2019-06-13actual | — | 2022-09-02 |
| Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSANCT02806895results2020-06-16Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: JZP-110, Placebo | Obstructive Sleep Apnea, Excessive Sleepiness | 34 | 2019-05-28actual | — | 2021-01-14 |
| An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With EpilepsyNCT02607904Number of participants who experienced an adverse event.Open-label · Treatment | Phase 2 | Completed | Drug: GWP42003-P | Epilepsy | 30 | 2019-05-27actual | — | 2022-12-20 |
| Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in NarcolepsyNCT02806908results2021-01-13Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)Randomized · Double-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Completed | Drug: JZP-110, Placebo | Narcolepsy, Excessive Sleepiness | 24 | 2019-05-19actual | — | 2021-01-13 |
| The Chimerix CMX001 RegistryNCT02167685observationalTime to all-cause mortality | — | Terminatedsponsor's stated reason: terminated due to low enrollment rate | Drug: CMX001 | Outcomes, Survival Rates | 550 | 2019-05-10actual | — | 2019-05-17 |
| The AdAPT Trial; Adenovirus After Allogeneic Pediatric TransplantationNCT03339401results2021-01-25Time-averaged Area Under the Concentration-time Curve for Plasma Adenovirus Viremia (Log10 Copies/mL).Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: terminated due to low enrollment rate | Other: Standard of Care · Drug: Brincidofovir | Adenovirus | 29 | 2019-05-10actual | — | 2021-01-25 |
| Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus ViremiaNCT03532035Plasma area under the curve (AUC) of BCVRandomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: terminated due to low enrollment rate | Drug: Brincidofovir, Standard of Care | Adenovirus | 0 | 2019-05-10actual | — | 2021-07-21 |
| CX-8998 for Absence SeizuresNCT03406702results2022-09-08Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: CX-8998 | Epilepsy | 7 | 2019-03-29actual | — | 2022-09-08 |
| A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With CataplexyNCT03030599results2020-11-12Change in Weekly Number of Cataplexy AttacksRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: JZP-258 · Other: Placebo | Narcolepsy With Cataplexy | 201 | 2019-01-24actual | — | 2020-11-12 |
| A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)NCT02544763results2020-09-23Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: GWP42003-P, Placebo | Tuberous Sclerosis Complex, Seizures | 224 | 2019-01-22actual | — | 2022-09-28 |
| A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With EpilepsyNCT02607891Maximum plasma concentration (Cmax) of STP, VPA, cannabidiol (CBD).Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GWP42003-P, Placebo | Epilepsy | 35 | 2018-09-11actual | — | 2022-12-20 |
| A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessNCT03037203results2020-01-09Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early DiscontinuationRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: JZP-110 · Other: Placebo | Excessive Sleepiness, Parkinson Disease | 66 | Aug 2018actual | — | 2020-01-09 |
| A Phase 2 RCT Study of CX-8998 for Essential TremorNCT03101241results2021-10-22Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: CX-8998, Placebo | Essential Tremor | 95 | 2018-07-16actual | — | 2021-11-23 |
| Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)NCT02953548results2020-07-23Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: GWP42003-P | Infantile Spasms | 9 | 2018-05-07actual | — | 2022-09-02 |
| GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeNCT02224703results2019-08-01Change In Convulsive Seizures During The Treatment Period Compared To BaselineRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: GWP42003-P, Placebo Control | Epilepsy, Dravet Syndrome | 199 | 2018-04-09actual | — | 2022-09-28 |
| "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"NCT02348632results2019-06-25Change in Epworth Sleepiness Scale (ESS) ScoreOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: JZP-110 | Narcolepsy, Obstructive Sleep Apnea | 645 | Dec 2017actual | — | 2019-06-25 |
| A Study of GWP42006 in People With Focal Seizures - Part BNCT02365610Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: GWP42006, Placebo Control | Epilepsy, Focal Seizures | 162 | Jul 2017actual | — | 2022-12-20 |
| Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic ImpairmentNCT02269579Total Drug Plasma PKOpen-label · Treatment | Phase 2 | Withdrawn | Drug: CPX-351 | Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) | 0 | Jun 2017 | — | 2018-03-14 |
| An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and CannabidiolNCT02564952results2018-09-11Number Of Participants Who Experienced Severe OLE-Emergent AEsOpen-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: GWP42003-P, Clobazam | Epilepsy | 18 | 2017-06-07actual | — | 2022-09-28 |
| A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With CataplexyNCT02221869results2019-04-30Change in Weekly Number of Cataplexy AttacksRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Xyrem | Narcolepsy With Cataplexy | 106 | Feb 2017actual | — | 2019-04-30 |
| "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"NCT02348593results2019-07-23Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: JZP-110, Placebo oral tablet | Narcolepsy | 239 | Feb 2017actual | — | 2019-07-23 |
| Patient Registry of Intrathecal Ziconotide Management(PRIZM)NCT01888120observationalThe effectiveness of PRIALT therapy for the management of severe chronic pain as evidenced by change in patient-reported pain intensity from baseline to 12 weeks after enrollment | — | Completed | Drug: Ziconotide | Patients With Severe Chronic Pain | 93 | Jan 2017actual | — | 2017-03-16 |
| "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"NCT02348606results2019-07-23Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: JZP-110, Placebo oral tablet | Obstructive Sleep Apnea | 476 | Dec 2016actual | — | 2019-07-23 |
| "Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"NCT02348619results2019-09-09Change in the Maintenance of Wakefulness Test (MWT)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: JZP-110 | Obstructive Sleep Apnea | 174 | Nov 2016actual | — | 2019-09-09 |
| A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 YearsNCT01898520Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS scoreRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Sativex, Placebo | Cerebral Palsy | 72 | Sep 2016actual | — | 2022-12-20 |
| Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND StudyNCT00628498results2017-11-30Survival by Day+100 Post Stem Cell Transplant or ChemotherapyOpen-label · Treatment | Phase 3 | Completed | Drug: Defibrotide, Defibrotide | Hepatic Veno-Occlusive Disease | 1,206 | Jul 2016actual | — | 2017-11-30 |
| A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and CannabidiolNCT02565108results2018-08-23Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GWP42003-P 20 mg/kg/Day Dose, Placebo, Clobazam | Epilepsy | 20 | 2016-07-21actual | — | 2022-09-28 |
| A Safety Study of Sativex Compared With Placebo (Both With Dose-intense Temozolomide) in Recurrent Glioblastoma PatientsNCT01812616Incidence of Adverse Events as a Measure of Patient Safety.Randomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: Sativex, Placebo | Cancer | 21 | Jun 2016actual | — | 2022-12-20 |
| Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus InfectionNCT02087306results2021-08-13Number of Participants With All-Cause MortalityOpen-label · Treatment | Phase 3 | Completed | Drug: Brincidofovir | Adenovirus Infection | 201 | Jun 2016actual | — | 2021-08-13 |
| A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304NCT02420080observationalCohort A (Time to progression of AdV disease through Week 36) | — | Terminatedsponsor's stated reason: Study was terminated early due to results from previous CMX study | Drug: Brincidofovir | Adenovirus | 100 | Jun 2016actual | — | 2017-01-09 |
| Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsNCT02224560results2018-07-27Percentage Change From Baseline In Drop Seizure Frequency During The Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GWP42003-P, Placebo control | Epilepsy, Lennox Gastaut Syndrome | 225 | 2016-05-19actual | — | 2022-09-28 |
| A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of CytomegalovirusNCT02439957results2021-07-16The Incidence of Cytomegalovirus (CMV) DiseaseRandomized · Triple-masked · Prevention | Phase 3 | Terminatedsponsor's stated reason: Study terminated early due to results from another CMX001 study. | Drug: Brincidofovir, Valganciclovir | Cytomegalovirus Disease, Kidney Transplant Infection | 6 | 2016-05-15actual | — | 2021-07-16 |
| A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsNCT02224690results2018-07-27Percentage Change From Baseline In Drop Seizure Frequency During The Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GWP42003-P 20 mg/kg/day Dose, Placebo | Epilepsy, Lennox-Gastaut Syndrome | 171 | 2016-03-18actual | — | 2022-09-28 |
| A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 DiabetesNCT02053272Change from baseline to the end of treatment in mean glycosylated haemoglobin A1c (HbA1c) level.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GWP42004, Placebo | Diabetes Mellitus, Type 2 | 207 | Feb 2016actual | — | 2022-12-20 |
| A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus DiseaseNCT02439970results2021-07-16The Incidence of CMV DiseaseRandomized · Triple-masked · Prevention | Phase 3 | Terminatedsponsor's stated reason: Study was terminated early due to results from another CMX001 study | Drug: Brincidofovir, Valganciclovir | Cytomegalovirus Disease | 5 | 2016-01-30actual | — | 2021-07-16 |
| Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related PainNCT01337089results2018-04-23Percent Of Participants With Treatment-emergent Adverse EventsOpen-label · Treatment | Phase 3 | Completed | Drug: Nabiximols | Pain, Advanced Cancer | 660 | 2016-01-27actual | — | 2023-04-12 |
| Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid LeukemiaNCT01696084results2017-10-02Overall SurvivalRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: CPX-351, 7+3 (cytarabine and daunorubicin) | High Risk Acute Myeloid Leukemia | 309 | 2015-12-31actual | — | 2020-08-10 |
| A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT RecipientsNCT01769170results2021-01-05Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-TransplantRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Brincidofovir · Other: Placebo | CMV | 452 | Dec 2015actual | — | 2021-07-21 |
| A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced CancerNCT02038699In Phase I, to determine the recommended phase II doses of ONC201.Open-label · Treatment | Phase 1/2 | Withdrawnsponsor's stated reason: Protocol not activated. | Drug: ONC201 | Advanced Glioblastoma, Advanced Colorectal Cancer, Advanced Triple-negative Breast Cancer, Advanced Non-small Cell Lung Cancer | 0 | Dec 2015 | — | 2021-04-30 |
| An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of EbolaNCT04268966The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVDOpen-label · Treatment | Phase 2 | Withdrawn | Drug: Brincidofovir | Ebola Virus Disease | 0 | Nov 2015 | — | 2020-02-26 |
| Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)NCT02091375results2018-07-20Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GWP42003-P 20 mg/kg/day Dose, Placebo control | Epilepsy, Dravet Syndrome | 120 | 2015-11-26actual | — | 2022-09-28 |
| A Study of GWP42006 in People With Focal Seizures - Part ANCT02369471Pharmacokinetic parameters of GWP42006 and metabolites: Cmax, Cmin, tmax, AUC(0-t), AUC(0-inf) and t1/2, in the presence of other AEDs.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: GWP42006, Placebo | Epilepsy, Focal Seizures | 32 | Oct 2015actual | — | 2022-12-20 |
| Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant RecipientsNCT04285788observationalNumber of participants with non-relapse related mortality 3 and 6 months after first AdV Virema in paediatric allo-HCT recipients | — | Completed | — | Adenovirus Infections, Human | 216 | Sep 2015actual | — | 2022-03-25 |
| A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced CancerNCT01424566results2018-04-23Change From Randomization Baseline In Mean NRS Average Pain At End Of TreatmentRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Nabiximols, Placebo (GA-0034) | Pain, Advanced Cancer | 406 | 2015-07-10actual | — | 2023-04-12 |
| An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)NCT02150928Serum asparaginase activity levelsOpen-label · Treatment | Phase 2 | Withdrawn | Drug: Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) | Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) | 0 | Jun 2015 | — | 2015-05-13 |
| An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS PatientsNCT02238925results2017-11-30Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)Open-label · Treatment | Phase 2 | Completed | Drug: CPX-351 | Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) | 26 | May 2015actual | — | 2017-11-30 |
| Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid LeukemiaNCT01843634Safety by incidence of serious eventsOpen-label · Treatment | Early Phase 1 | Completed | Drug: ODSH | Acute Myeloid Leukemia | 10 | Apr 2015actual | — | 2021-11-10 |
| A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)NCT02091206results2018-07-19Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GWP42003-P 5 mg/kg/day Dose, Placebo control, GWP42003-P 10 mg/kg/day Dose, GWP42003-P 20 mg/kg/day Dose | Epilepsy, Dravet Syndrome | 34 | 2015-03-09actual | — | 2022-09-28 |
| Phase I Study of mPEG-R-Crisantaspase Given IVNCT01551524Maximum Tolerated DoseOpen-label · Treatment | Phase 1 | Completed | Biological: mPEG-r-crisantaspase | Hematologic Malignancies | 36 | Feb 2015actual | — | 2015-05-07 |
| A Pilot Study of Dociparstat Sodium (ODSH) in Acute Myeloid LeukemiaNCT02056782results2023-02-21Time (Days) to Transfusion-independent Platelet Recovery (Platelet Counts Values ≥ 20,000/μL and ≥ 50,000/μL Without a Platelet Transfusion)Open-label · Treatment | Phase 1 | Completed | Drug: Dociparstat sodium | Acute Myeloid Leukemia | 12 | Feb 2015actual | — | 2023-02-21 |
| A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)NCT02257684results2017-02-23The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor decision | Drug: pegcrisantaspase | Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma | 4 | Feb 2015actual | — | 2017-04-04 |
| An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.NCT02325011Pharmacokinetic parameters of Δ9 Tetrahydrocannabinol (THC): Cmax, AUC(0-t) and AUC(0-∞)Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Sativex® (Treatment A), Sativex® and fluconazole concomitantly (Treatment B) | Healthy Subjects | 14 | Feb 2015actual | — | 2022-12-20 |
| A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent GlioblastomaNCT01812603The incidence of adverse events in patients receiving Sativex in combination with dose-intense Temozolomide in the open-label phase of the studyOpen-label · Treatment | Phase 1/2 | Completed | Drug: Sativex | Cancer | 6 | Jan 2015actual | — | 2022-12-20 |
| An Observational Post-Marketing Safety Registry of Sativex®NCT02073474observationalIncidence rates of adverse events. | — | Completed | Drug: Sativex® | Multiple Sclerosis, Diabetes, Cancer, Neuropathic Pain | 978 | Jan 2015actual | — | 2022-12-20 |
| An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus DiseaseNCT02271347Number of Participants with Adverse Events as a Measure of Safety and Tolerability.Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Suspended Development Program | Drug: CMX001 | Ebola Virus | 0 | Jan 2015actual | — | 2015-02-02 |
| A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic DisorderNCT02006628results2019-07-26Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, GWP42003 | Schizophrenia, Schizophrenia-related Psychotic Disorder | 88 | 2015-01-08actual | — | 2022-09-28 |
| Sativex® for Relieving Persistent Pain in Patients With Advanced CancerNCT01361607results2018-04-23Percent Improvement From Baseline In Mean NRS Average Pain At End Of TreatmentRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Nabiximols, Placebo (GA-0034) | Pain, Advanced Cancer | 399 | 2014-11-24actual | — | 2023-04-12 |
| Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy PatientsNCT01887301Pharmacokinetic analysis - Unbound maximum plasma concentration (Cmax(u)) of Sativex® in healthy patients and in patients with hepatic impairmentNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Sativex | Hepatic Impairment | 32 | May 2014actual | — | 2022-12-20 |
| A Study of the Safety and Tolerability of GWP42006 in Healthy SubjectsNCT01918735The incidence of adverse events as measure of subject safetyRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Placebo, GWP42006 | Epilepsy | 66 | Dec 2013actual | — | 2022-12-20 |
| A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase TherapyNCT01643408results2021-06-23Two Day Nadir Serum Asparaginase Activity (NSAA) LevelOpen-label · Treatment | Phase 2 | Completed | Drug: asparaginase Erwinia chrysanthemi | Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma | 30 | Aug 2013actual | — | 2021-06-23 |
| A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With NarcolepsyNCT01681121results2014-09-11Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: ADX-N05, Placebo | Narcolepsy | 93 | Aug 2013actual | — | 2021-05-28 |
| Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus DiseaseNCT01241344results2021-07-16Number of Participants With Clinically Significant AdV InfectionRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Brincidofovir · Other: Placebo | Adenovirus Disease | 52 | Jun 2013actual | — | 2021-07-21 |
| A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis PatientsNCT01964547results2014-05-02Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.Randomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Sativex, Placebo | Multiple Sclerosis, Spasticity | 121 | May 2013actual | — | 2023-01-12 |
| Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA VirusesNCT01143181results2021-08-12Number of Subjects Who Had a Sustained and Significant Reduction in Plasma Viral Load of Primary dsDNA VirusOpen-label · Treatment | Phase 3 | Completed | Drug: Brincidofovir | Double-stranded DNA Virus | 210 | Dec 2012actual | — | 2021-08-12 |
| Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer PatientsNCT01461915Number of Patients who Achieved Progression-Free SurvivalRandomized · Open-label · Treatment | Phase 2 | Terminated | Drug: Nab paclitaxel, Gemcitabine, Dociparstat | Metastatic Pancreatic Cancer | 60 | Dec 2012actual | — | 2022-06-06 |
| GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II DiabetesNCT01217112results2014-01-20The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of TreatmentRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: GWP42003, GWP42003, GWP42004, Placebo | Dyslipidemias, Diabetes Mellitus, Type 2 | 62 | May 2012actual | — | 2022-10-18 |
| A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime SleepinessNCT01485770results2021-07-06Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With PlaceboRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: ADX-N05, Placebo | Narcolepsy | 33 | May 2012actual | — | 2021-07-06 |
| Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative SurgeryNCT01161641Clinical improvement of PLE symptoms and signs.Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Extremely slow accural due to rarity of medical condition studied. | Drug: ODSH at 0.125 mg/kg/h, ODSH at 0.375 mg/kg/h, ODSH at 0.250 mg/kg/h | Protein Losing Enteropathy | 5 | Feb 2012actual | — | 2021-12-02 |
| Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant RecipientsNCT00942305results2021-07-16Number of Participants With Clinically Significant CMV InfectionRandomized · Double-masked · Prevention | Phase 2 | Completed | Drug: Brincidofovir, Placebo | Cytomegalovirus Infection | 239 | Jan 2012actual | — | 2021-07-16 |
| Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)NCT00822094results2017-09-29Proportion of Subjects Surviving at 1 YearRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: CPX-351, Intensive Salvage Therapy | Acute Myeloid Leukemia | 126 | Dec 2011actual | — | 2017-11-24 |
| Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy SubjectsNCT05391724Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0Open-label · Other | Phase 1 | Completed | Drug: CMX001 | Hepatic Impairment | 25 | Sep 2011actual | — | 2022-05-26 |
| A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy VolunteersNCT01080820Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogramRandomized · Double-masked | Phase 1 | Completed | Drug: CMX157, Placebo, Viread | Healthy | 36 | Dec 2010actual | — | 2011-07-04 |
| Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck CancerNCT00901732The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.Non-randomized · Open-label · Health services research | Phase 1/2 | Unknown status | Device: Caphosol | Oral Mucositis | 100 | Nov 2010 | — | 2009-05-14 |
| CMX001 in Post-transplant Patients With BK Virus ViruriaNCT00793598results2021-07-16Number of Adverse Events in Post-Transplant Patients With BK Virus ViruriaRandomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: Placebo, Brincidofovir | Viruria | 29 | Oct 2010actual | — | 2021-08-16 |
| Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With FibromyalgiaNCT00803023results2011-08-16Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study SubjectsRandomized · Single-masked · Treatment | Phase 3 | Completed | Drug: Sodium Oxybate, Sodium Oxybate & 6 Tablets, Sodium Oxybate & 8 Tablets, Sodium Oxybate Oral Solution (6 grams) | Fibromyalgia | 129 | Jul 2010actual | — | 2011-08-19 |
| Trial of CPX-351 in Newly Diagnosed Elderly AML PatientsNCT00788892results2018-01-12Number of Participants With Complete RemissionRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: CPX-351, Cytarabine, Daunorubicin | Acute Myeloid Leukemia | 126 | Jun 2010actual | — | 2018-01-12 |
| Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.NCT00423605results2011-10-20Number of Subjects Reporting Adverse EventsNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Xyrem® | Fibromyalgia | 560 | Jan 2010actual | — | 2012-03-30 |
| A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPDNCT00457951results2016-12-16Incidence of Treatment FailureRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Interim analysis: safety without efficacy ODSH in patients with acute COPD. | Drug: Open-Label, Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride, ODSH | Chronic Obstructive Pulmonary Disease | 158 | Aug 2009actual | — | 2021-12-02 |
| A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.NCT00423813results2012-01-10Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: placebo, Xyrem® | Fibromyalgia | 573 | Apr 2009actual | — | 2012-01-24 |
| A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)NCT00681538results2011-12-07The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex®, Placebo | Spasticity, Multiple Sclerosis | 572 | Jan 2009actual | — | 2023-05-06 |
| Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple SclerosisNCT00702468results2011-06-17Number of Subjects Who Experience Treatment Failure.Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex, Placebo | Spasticity, Multiple Sclerosis | 36 | Jan 2009actual | — | 2023-05-06 |
| Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal CancerNCT00361842results2021-07-02Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection | Colorectal Neoplasms | 65 | Dec 2008actual | — | 2021-07-02 |
| Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.NCT00389428To determine the maximum tolerated dose (MTD) for use in phase 2Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CPX-351 (Cytarabine:Daunorubicin) Liposome Injection | Hematologic Neoplasms | 48 | Dec 2008actual | — | 2012-05-17 |
| Study of Intranasal Clonazepam in Adult Subjects With Epileptic SeizuresNCT00594945results2014-07-01Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Clonazepam | Epilepsy | 45 | Dec 2008actual | — | 2014-07-01 |
| A Study to Compare the Efficacy of Rapydan Versus Tetracaine GelNCT00670696To demonstrate superiority for Rapydan medicated plaster applied 30 minutes over tetracaine gel applied for 45 minutes in terms of reducing pain associated with venous cannulation as assessed by the subject on a 100 mm visual analog scale (VAS)Randomized · Single-masked · Treatment | Phase 4 | Withdrawnsponsor's stated reason: No longer sponsor of trial | Drug: Rapydan, tetracaine gel | Healthy, Anesthesia | 0 | Dec 2008 | — | 2012-04-25 |
| Comparative Bioavailability and Effect of Food on CMX001 in Healthy VolunteersNCT00780182AUC and Cmax of CMX001 and cidofovirRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: CMX001 | Healthy | 24 | Dec 2008actual | — | 2010-02-02 |
| Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant PatientsNCT00358501results2017-01-30Survival at Day+100 Following Hematopoietic Stem Cell TransplantNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Defibrotide | Severe Hepatic Veno-Occlusive Disease | 134 | Sep 2008actual | — | 2017-01-30 |
| A Safety and Efficacy Study of Xyrem® in Subjects With FibromyalgiaNCT00371137results2011-11-30Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Xyrem®, Placebo | Fibromyalgia | 548 | Sep 2008actual | — | 2011-12-29 |
| Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential TremorNCT00598078results2012-01-23Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice TremorRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Sodium Oxybate, Sodium Oxybate · Other: Placebo | Essential Tremor | 19 | Aug 2008actual | — | 2012-01-23 |
| Sativex Thorough QT/QTc StudyNCT01322139Time-matched change from baseline in QTc based on an individual correction (QTcl)Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: Placebo spray and oral moxifloxacin placebo, Sativex spray and oral moxifloxacin placebo, Sativex spray and oral moxifloxacin placebo, Placebo spray and moxifloxacin | Effects of Sativex on ECG | 258 | Jun 2008actual | — | 2023-04-10 |
| Abuse Potential of SativexNCT01323569Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and SativexRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: Sativex, Sativex, Sativex, Placebo, Marinol, Marinol | Evaluation of Abuse Potential of Sativex | 58 | Jun 2008actual | — | 2023-04-10 |
| Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of SativexNCT01323465Pharmacokinetic analysis - Cmax of Sativex® alone and of Sativex® with concomitant administration of rifampicin, ketoconazole, and omeprazoleRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Sativex and rifampicin, Sativex and rifampicin, Sativex and ketoconazole, Sativex and ketoconazole, Sativex and omeprazole, Sativex and omeprazole | Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor | 36 | Mar 2008actual | — | 2023-04-10 |
| Study to Assess Food Effect on Sativex BioavailabilityNCT01322464Primary PK EndpointsRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Sativex, Sativex, Sativex, Sativex | Food Effect | 25 | Feb 2008actual | — | 2023-04-10 |
| Trial of Xyrem® (Sodium Oxybate) for the Treatment of NarcolepsyNCT00132873results2013-11-25Adverse ExperiencesNon-randomized · Open-label | Phase 3 | Completed | Drug: Xyrem (sodium oxybate) oral solution | Narcolepsy | 59 | Sep 2007actual | — | 2013-11-25 |
| A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic PainNCT00713817results2012-08-16Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex®, Placebo | Pain, Peripheral Neuropathy | 19 | Jul 2007actual | — | 2023-05-03 |
| A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.NCT00713323results2012-09-14Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label TreatmentOpen-label · Supportive care | Phase 3 | Completed | Drug: Sativex® | Pain, Peripheral Neuropathy | 380 | Jun 2007actual | — | 2023-05-03 |
| A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With AllodyniaNCT00710554results2012-09-14Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex, Placebo | Pain, Peripheral Neuropathy | 246 | Oct 2006actual | — | 2023-05-03 |
| Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related PainNCT00675948results2012-09-13The Incidence of Adverse Events as a Measure of Subject SafetyNon-randomized · Open-label · Supportive care | Phase 3 | Completed | Drug: Sativex, GW-2000-02 | Pain, Cancer | 43 | Sep 2006actual | — | 2023-05-03 |
| A Study of Sativex® for Pain Relief Due to Diabetic NeuropathyNCT00710424results2012-07-31The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex, Placebo | Pain, Diabetic Neuropathy | 297 | Jun 2006actual | — | 2023-05-03 |
| A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple SclerosisNCT01599234results2012-08-16Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Sativex, Placebo | Multiple Sclerosis | 337 | Dec 2005actual | — | 2023-05-03 |
| A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple SclerosisNCT00678795results2012-09-21Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of TreatmentRandomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex®, Placebo | Detrusor Overactivity, Multiple Sclerosis | 135 | Oct 2005actual | — | 2023-05-03 |
| Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea PatientsNCT00086281results2012-02-24The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).Randomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: Xyrem (X), Zolpidem (Z), Modafinil (M), Placebo (P) | Obstructive Sleep Apnea Syndrome | 60 | Jun 2005actual | — | 2012-02-24 |
| Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of FibromyalgiaNCT00087555results2012-01-10The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Xyrem (sodium oxybate) oral solution, Xyrem (sodium oxybate) oral solution, Placebo | Fibromyalgia | 195 | Apr 2005actual | — | 2012-01-24 |
| A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisNCT01610687results2012-08-17Incidence of Adverse Events as a Measure of Patient SafetyOpen-label · Treatment | Phase 3 | Completed | Drug: GW-1000-02 | Multiple Sclerosis, Spasticity | 137 | Feb 2005actual | — | 2023-01-10 |
| A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord InjuryNCT01606202results2012-09-28Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GW-1000-02, Placebo | Pain | 116 | Jan 2005actual | — | 2023-01-10 |
| A Study of the Long-term Safety of Sativex UseNCT01606137results2012-08-23Incidence of Adverse Events as a Measure of Subject Safety.Open-label · Treatment | Phase 3 | Completed | Drug: GW-1000-02 | Multiple Sclerosis, Spasticity, Pain | 507 | Dec 2004actual | — | 2023-05-06 |
| Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in NarcolepsyNCT00066170results2011-11-30Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Xyrem, Xyrem Placebo, Modafinil at established dose, Modafinil (Placebo) | Narcolepsy | 231 | Jul 2004actual | — | 2011-12-29 |
| A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.NCT00711646results2012-09-14Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex®, Placebo | Spasticity, Multiple Sclerosis | 189 | Mar 2004actual | — | 2023-05-06 |
| A Study of Sativex® for Relief of Peripheral Neuropathic Pain Associated With Allodynia.NCT00711880results2012-09-28Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Sativex®, Placebo | Pain, Peripheral Neuropathy | 125 | Mar 2004actual | — | 2023-04-12 |
| A Study of Sativex® for Pain Relief in Patients With Advanced MalignancyNCT00674609results2012-08-13The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: Placebo, Sativex®, THC Alone | Palliative Care, Pain, Cancer | 177 | Feb 2004actual | — | 2023-05-03 |
| A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury PainNCT01606189results2012-11-19Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GW-1000-02, GW-2000-02, Placebo | Pain | 48 | Sep 2002actual | — | 2023-01-10 |
| A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple SclerosisNCT01604265results2012-09-19Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Sativex | Multiple Sclerosis, Neuropathic Pain | 66 | Aug 2002actual | — | 2023-01-10 |
| A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological OriginNCT01606176results2012-08-24Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GW-1000-02, Placebo | Pain, Multiple Sclerosis | 70 | Aug 2002actual | — | 2023-01-10 |
| An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis PatientsNCT01610700results2012-09-19Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of TreatmentRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: GW-1000-02, Placebo | Multiple Sclerosis | 160 | Jul 2002actual | — | 2023-01-12 |
| An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisNCT01610713results2012-09-19Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)Open-label · Treatment | Phase 3 | Completed | Drug: GW-1000-02 | Multiple Sclerosis | 154 | Jul 2002actual | — | 2023-01-10 |
| Experimental Medication For the Treatment of Generalized Anxiety DisorderNCT00097708results2014-10-03Change in HAM-A Total ScoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: experimental anti-anxiety drug | Anxiety Disorder | 511 | — | — | 2014-10-03 |
| A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety DisorderNCT00106860Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: a benzodiazepine drug | Anxiety Disorder | 158 | — | — | 2008-01-09 |
| EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AMLNCT02533115expanded access | — | Approved for marketing | Drug: CPX-351 | Secondary AML | — | — | — | 2017-08-22 |
| Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or DiseaseNCT02596997expanded access | — | No longer available | Drug: Brincidofovir | Adenovirus | — | — | — | 2022-03-14 |
| Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High Grade GliomasNCT03134131expanded access | — | No longer available | Drug: ONC201 | Glioma | — | — | — | 2022-03-14 |
| A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USANCT04291937expanded access | — | Approved for marketing | Drug: Lurbinectedin | Small Cell Lung Cancer | — | — | — | 2020-06-19 |
| An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract CancerNCT04578444expanded access | — | No longer available | Drug: Zanidatamab | HER2-Positive Advanced Biliary Tract Cancer | — | — | — | 2025-05-25 |
| Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline GliomasNCT04617002expanded access | — | Approved for marketing | Drug: ONC201 (dordaviprone) | Glioma, H3 K27M | — | — | — | 2025-08-20 |
| JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. Coli-derived AsparaginaseNCT04943952expanded access | — | Approved for marketing | Drug: Asparaginase Erwinia Chrysanthemi (recombinant) | Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma | — | — | — | 2021-08-03 |
| Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine GliomasNCT05392374expanded access | — | No longer available | Drug: ONC201 | Glioma | — | — | — | 2022-05-26 |
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