DKK 43.14
+0.62 (+1.46%)
DKK · as of 2026-08-17 · marketstack
Clinical trials
catalyst calendar across sponsors →Studies where HLUN-B.CO 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.
219 interventional · 3 observational · 63 with posted results
Held by 0 tracked-famous managers · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor FluctuationsNCT07514858Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary EntriesRandomized · Quadruple-masked · Treatment | Phase 2 | Not yet recruiting | Drug: Lu AF28996, Placebo | Parkinson's Disease | 150 | 2028-12-30 | in 864 d | 2026-04-07 |
| A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic MigraineNCT05164172Number of Participants With Treatment Emergent Adverse EventsRandomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Eptinezumab | Migraine | 600 | 2028-04-30 | in 620 d | 2026-06-12 |
| A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)NCT06706622Rest of the World (RoW; All Countries Except European Union [EU] and Japan [JP]) Regional-specific Outcome Measure: Mortality-adjusted Clinical ProgressionRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Amlenetug, Placebo | Multiple System Atrophy | 401 | 2028-02-17 | in 547 d | 2026-07-14 |
| A Study of Eptinezumab in Pediatric Participants With Episodic MigraineNCT05897320Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Eptinezumab, Placebo | Episodic Migraine | 315 | 2027-07-06 | in 321 d | 2026-07-14 |
| A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD)NCT07513441Number of Participants With Treatment-emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 1 | Recruiting | Drug: Lu AF28996 | Parkinson Disease | 10 | 2027-05-31 | in 285 d | 2026-08-10 |
| A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have NarcolepsyNCT07613710Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: Lu AH69593, Placebo | Narcolepsy | 104 | 2027-02-09 | in 174 d | 2026-08-12 |
| A Trial of Lu AG13909 in Participants With Congenital Adrenal HyperplasiaNCT05669950Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Lu AG13909 | Congenital Adrenal Hyperplasia | 42 | 2026-09-30 | in 42 d | 2026-03-09 |
| A Trial of Lu AG13909 in Adult Participants With Cushing's DiseaseNCT06471829Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration PeriodOpen-label · Treatment | Phase 2 | Recruiting | Drug: Lu AG13909 | Cushing's Disease | 18 | 2026-09-15 | in 27 d | 2026-06-12 |
| A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic MigraineNCT04965675Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Eptinezumab, Placebo | Chronic Migraine in Children | 285 | 2026-09-05 | in 17 d | 2026-07-14 |
| A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP MedicationsNCT06701526Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) ScaleOpen-label · Treatment | Phase 4 | Active, not recruiting | Drug: Eptinezumab | Migraine | 164 | 2026-06-05 | — | 2026-05-13 |
| A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye DiseaseNCT06557850Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel ExophthalmometerOpen-label · Treatment | Phase 1 | Active, not recruiting | Drug: Lu AG22515 | Thyroid Eye Disease | 20 | 2026-03-17actual | — | 2026-06-12 |
| Observational Study in Multiple System AtrophyNCT05453058observationalTo describe early MSA disease progression changes in 6-month intervals over 12-months (i.e., baseline, 6-months, 12-months) | — | Active, not recruiting | Diagnostic test: plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort | Multiple System Atrophy | 90 | 2024-03-12actual | — | 2025-12-08 |
| A Study of Lu AF82422 in Participants With Multiple System AtrophyNCT05104476results2024-12-27Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Active, not recruiting | Drug: Lu AF82422, Placebo | Multiple System Atrophy | 64 | 2023-11-16actual | — | 2026-04-13 |
| A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive TreatmentsNCT06323928Change From Baseline in the Number of Monthly Migraine Days (MMDs)Randomized · Double-masked · Prevention | Phase 2 | Completed | Drug: Lu AG09222, Placebo | Migraine | 874 | 2026-01-16actual | — | 2026-06-12 |
| Lu AF28996 in Participants With Parkinson's Disease (PD)NCT04291859Number of Participants with Treatment-emergent Adverse EventsOpen-label · Treatment | Phase 1 | Completed | Drug: Lu AF28996 | Parkinson Disease | 57 | 2025-10-14actual | — | 2026-03-06 |
| A Trial Investigating Lu AG09222 With Ubrogepant in Participants With MigraineNCT06578585Number of participants with treatment-emergent adverse events (TEAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Ubrogepant, Lu AG09222, Placebo | Migraine | 43 | 2025-07-11actual | — | 2025-10-14 |
| A Study of Eptinezumab in Participants With Migraine and Medication Overuse HeadacheNCT05452239results2025-12-04Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4Randomized · Double-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Eptinezumab, Placebo | Migraine, Medication Overuse Headache | 608 | 2024-10-22actual | — | 2026-01-29 |
| Eptinezumab as Preventive Treatment of Migraine in Adults With MigraineNCT04921384Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Eptinezumab | Migraine | 981 | 2024-10-01actual | — | 2026-01-14 |
| A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian AdultsNCT06258720Number of participants with treatment-emergent adverse events (safety and tolerability)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF82422 | Healthy Participants | 24 | 2024-09-03actual | — | 2024-11-12 |
| A Study Investigating Lu AG06474 in Healthy Young ParticipantsNCT05943327Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: For strategic reasons | Drug: Lu AG06474, Placebo, Lu AG06474 | Healthy Participants | 56 | 2024-07-19actual | — | 2024-11-18 |
| Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in JapanNCT05064371Number of Participants With Adverse Events (AEs)Open-label · Treatment | Phase 3 | Completed | Drug: Eptinezumab | Migraine | 160 | 2024-06-08actual | — | 2026-01-14 |
| A Trial Investigating Lu AF28996 in Healthy Adult ParticipantsNCT06277609Maximum Observed Concentration (Cmax) of Lu AF28996Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF28996, Acetylsalicylic Acid, Mefenamic Acid, Amoxicillin/clavulanic acid | Healthy Participants | 22 | 2024-05-19actual | — | 2024-06-11 |
| A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy MenNCT06337110Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF28996 | Healthy Participants | 8 | 2024-05-11actual | — | 2024-10-04 |
| A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult ParticipantsNCT06077786Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain TestRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AG06474, Placebo to Lu AG06474, Ibuprofen, Pregabalin, Placebo | Healthy Participants | 26 | 2024-05-10actual | — | 2024-06-28 |
| A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)NCT06004180Number of Participants With Treatment-emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF28996 | Parkinson Disease | 6 | 2023-11-21actual | — | 2023-12-11 |
| A Study Investigating Lu AG22515 in Healthy AdultsNCT05136053Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: Lu AG22515, Placebo, Immune System Activator | Healthy Participants | 58 | 2023-08-05actual | — | 2023-08-28 |
| Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's DiseaseNCT04149860Number of Participants with Treatment Emergent Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AF87908, Placebo | Healthy, Alzheimer Disease | 86 | 2023-07-19actual | — | 2023-08-04 |
| A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)NCT05064397results2024-08-06Number of Participants With Treatment-emergent Adverse Events (AEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Eptinezumab | Chronic Cluster Headache | 131 | 2023-06-29actual | — | 2024-08-06 |
| Eptinezumab in Participants With Episodic Cluster HeadacheNCT04688775results2024-08-09Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Eptinezumab, Placebo | Cluster Headache, Episodic | 231 | 2023-06-14actual | — | 2024-08-09 |
| Real World Effectiveness of Eptinezumab in Participants With MigraineNCT05284019results2024-05-29Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Terminatedsponsor's stated reason: The study was terminated due to enrolment challenges. | Drug: Eptinezumab, Erenumab, Onabotulinumtoxin-A, Fremanezumab, Galcanezumab | Migraine | 32 | 2023-02-17actual | — | 2024-05-29 |
| Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)NCT04597450Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition TaskRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AG06466, Placebo | PTSD | 35 | 2023-02-13actual | — | 2023-03-24 |
| A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple SclerosisNCT04990219Number of Participants with Spasticity ResponseRandomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated for strategic reasons | Drug: Lu AG06466, Placebo | Multiple Sclerosis | 37 | 2023-01-19actual | — | 2023-02-03 |
| A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive TreatmentsNCT05133323results2024-02-08Change From Baseline in the Number of Monthly Migraine Days (MMDs)Randomized · Double-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Lu AG09222, Placebo | Migraine | 237 | 2023-01-19actual | — | 2024-03-13 |
| Safety and Tolerability of Lu AG06474 in Healthy Young MenNCT05003687Parts A and B: Number of participants With Treatment-Emergent Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AG06474, Placebo | Healthy | 79 | 2022-12-22actual | — | 2023-01-09 |
| A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese ParticipantsNCT05304910Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AG09222, Placebo | Migraine | 52 | 2022-10-30actual | — | 2022-11-10 |
| A Study in Children and Young People With Migraine to Learn What the Body Does to EptinezumabNCT04537429Area under curve (AUC) (0-infinity) eptinezumabOpen-label · Treatment | Phase 1 | Completed | Drug: Eptinezumab | Migraine in Children, Migraine | 28 | 2022-10-20actual | — | 2023-10-06 |
| Binding and Effects of Lu AG06466 in the Brain of Healthy MenNCT05219838Plasma Concentration of Lu AG06466 and Lu AG06988Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AG06466 | Healthy Participants | 8 | 2022-08-18actual | — | 2022-09-09 |
| Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic HypotensionNCT02586623results2023-08-23Time To InterventionRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Droxidopa capsules, Placebo capsules | Symptomatic Neurogenic Orthostatic Hypotension | 453 | 2022-07-21actual | — | 2023-08-23 |
| A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell LinesNCT05074459Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Eptinezumab Mammalian Cell Line, Eptinezumab Yeast Cell Line | Healthy Participants | 84 | 2022-07-18actual | — | 2022-08-29 |
| A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass PollenNCT05126316Number of Participants With Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Lu AG09222, Placebo | Allergic Rhinitis | 30 | 2022-07-12actual | — | 2022-10-27 |
| Vortioxetine in Patients With Depression and Early DementiaNCT04294654Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total scoreOpen-label · Treatment | Phase 4 | Completed | Drug: Vortioxetine | Major Depressive Disorder, Dementia | 82 | 2022-07-06actual | — | 2022-08-08 |
| A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male ParticipantsNCT05320302Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370Open-label · Treatment | Phase 1 | Completed | Drug: [11C]-Lu AF88370 | Healthy Participants | 6 | 2022-06-15actual | — | 2022-07-14 |
| A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male ParticipantsNCT05306366Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)Open-label · Treatment | Phase 1 | Completed | Drug: [11C]-Lu AF90103 | Healthy Young Men | 8 | 2022-06-07actual | — | 2022-07-14 |
| Eptinezumab in Adults With Migraine and Medication Overuse HeadacheNCT04772742Change from baseline in the number of monthly migraine days (MMDs)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Eptinezumab | Migraine, Medication Overuse Headache | 193 | 2022-05-23actual | — | 2022-10-31 |
| A Study of Lu AG06466 in Participants With Treatment Resistant Focal EpilepsyNCT05081518Number of "Long Episodes" (Electrocorticographic [ECoG] Seizures)Randomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated due to enrolment challenges | Drug: Lu AG06466, Placebo | Focal Epilepsy | 1 | 2022-04-14actual | — | 2022-11-09 |
| Vortioxetine to Prevent Return of Symptoms in Children With DepressionNCT05014919results2023-01-05Time to Relapse in the Double-blind PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated based on new efficacy data from another study. | Drug: Vortioxetine, Placebo | Depression | 35 | 2022-03-31actual | — | 2023-01-05 |
| Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of AgeNCT02871297results2022-12-28Number 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 based on new efficacy data from another study. | Drug: Vortioxetine | Depressive Disorder, Major | 662 | 2022-03-25actual | — | 2022-12-28 |
| A Study Investigating Lu AG06466 in Healthy MenNCT05201092Cumulative Percent Recovery of Radioactivity in UrineOpen-label · Treatment | Phase 1 | Completed | Drug: [14C]-Lu AG06466 | Healthy Volunteers | 6 | 2022-02-19actual | — | 2022-03-16 |
| Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in IndiaNCT04288895Number of participants with Treatment-Emergent Adverse EventsOpen-label · Treatment | Phase 4 | Completed | Drug: Vortioxetine | Major Depressive Disorder | 400 | 2022-02-11actual | — | 2022-03-18 |
| A Study to Evaluate Lu AG06466 in Participants With FibromyalgiaNCT04974359Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain TestRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study terminated due to enrolment challenges. | Drug: Lu AG06466, Placebo | Fibromyalgia | 3 | 2022-01-26actual | — | 2022-02-11 |
| Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)NCT02709655results2022-09-22Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase BRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20mg/day · Other: Placebo | Depressive Disorder, Major | 683 | 2022-01-21actual | — | 2022-09-22 |
| Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From DepressionNCT04448431Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total scoreRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Vortioxetine, Desvenlafaxine | Major Depressive Disorder | 605 | 2022-01-06actual | — | 2022-02-14 |
| A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy ParticipantsNCT05028673Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AG06466 Capsule, Lu AG06466 Tablet, Antacid | Healthy | 16 | 2021-12-29actual | — | 2022-01-21 |
| Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian ParticipantsNCT05177029Part A: Number of Participants With Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated for strategic reasons. | Drug: Lu AG06466, Placebo | Healthy Volunteers | 24 | 2021-12-29actual | — | 2022-07-12 |
| A Study to Evaluate Lu AF90103 in Healthy MenNCT04940949Number of Participants With Treatment-Emergent Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated based on new safety data. | Drug: Lu AF90103, Placebo | Healthy | 15 | 2021-11-23actual | — | 2023-03-16 |
| Safety and Tolerability of Lu AG06479 in Healthy Young MenNCT04473651Number of participants with treatment emergent adverse events (Safety and Tolerability)Randomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated for strategic reasons. | Drug: Lu AG06479, Placebos | Healthy | 46 | 2021-11-10actual | — | 2021-12-14 |
| A Single Dose Study of Lu AG09222 in a Headache Model With Healthy SubjectsNCT04976309Area under the curve (AUC) of change from start of infusion in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AG09222, Placebo | Healthy | 25 | 2021-09-19actual | — | 2022-01-19 |
| Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseNCT03611569Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AF82422, Placebo | Healthy, Parkinson Disease | 74 | 2021-07-26actual | — | 2021-10-12 |
| Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese SubjectsNCT05045781AUC(0-inf) eptinezumabRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Eptinezumab | Healthy | 20 | 2021-07-20actual | — | 2021-09-16 |
| A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive TreatmentsNCT04418765results2022-07-22Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Eptinezumab, Placebo | Migraine | 892 | 2021-07-15actual | — | 2023-09-29 |
| Drug Drug Interaction Study With Lu AG06466 in Young Healthy MenNCT04713254AUC 0-inf for midazolamOpen-label · Treatment | Phase 1 | Completed | Drug: Lu AG06466 · Other: Midazolam, Metoprolol, Bupropion | Healthy | 15 | 2021-04-09actual | — | 2021-04-20 |
| Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)NCT04220996Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total scoreOpen-label · Treatment | Phase 4 | Completed | Drug: Vortioxetine | MDD, Anxiety Disorders | 100 | 2021-03-09actual | — | 2021-04-20 |
| Binding of Lu AG06466 in the Brain in Healthy MenNCT04419636Central monoacylglycerol lipase (MAGL) occupancyRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AG06466 | Healthy | 16 | 2021-02-09actual | — | 2021-02-24 |
| Real-life Effectiveness of Vortioxetine in DepressionNCT03555136observationalSheehan Disability Scale (SDS) | — | Completed | Drug: Vortioxetine | Major Depressive Disorder | 992 | 2021-01-31actual | — | 2021-05-27 |
| A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the BrainNCT04538014Total distribution volume (VT) of [11C]-Lu AF88434Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF88434, [11C]-Lu AF88434 | Healthy | 8 | 2020-10-21actual | — | 2021-02-24 |
| Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young MenNCT04082325Number of participants with treatment-emergent adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AF88434, Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434), Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434), Placebo | Healthy | 68 | 2020-09-24actual | — | 2021-02-24 |
| Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative SymptomsNCT03929497Number of participants with Treatment-Emergent Adverse EventsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Lack of efficacy based on the interim analysis in the 17972A study | Drug: Lu AF11167 | Schizophrenia | 96 | 2020-09-01actual | — | 2020-09-23 |
| Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With SchizophreniaNCT03793712Change in Negative Symptom Scale (BNSS) total scoreRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Lack of efficacy based on interim analysis | Drug: Lu AF11167 (1-2 mg/day), Lu AF11167 (3-4 mg/day), Placebo | Schizophrenia | 168 | 2020-08-20actual | — | 2020-09-23 |
| Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and WomanNCT04197349Number of participants with treatment-emergent adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Biological: ALD1910, Sumatriptan, ALD1910 | Migraine | 96 | 2020-08-19actual | — | 2020-09-23 |
| Eptinezumab in Healthy Japanese SubjectsNCT04336449Cmax eptinezumabRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Eptinezumab, Placebo | Healthy | 18 | 2020-08-13actual | — | 2020-08-14 |
| Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and WomenNCT04405323AUC(0-inf) Lu AG06466Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AG06466, Itraconazole | Healthy | 16 | 2020-07-28actual | — | 2020-08-14 |
| A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of MigraineNCT04152083results2021-08-16Time to Headache Pain FreedomRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Eptinezumab, Placebo | Migraine | 485 | 2020-07-08actual | — | 2021-08-17 |
| Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy SubjectsNCT04322227Latency of EEG movement related desynchronization of the μ-oscillationsRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study termination due to efficacy results of another study | Drug: Foliglurax 10 mg (treatment A), Foliglurax 30 mg (treatment B), Placebo (treatment C) | Parkinson Disease, Healthy | 6 | 2020-05-30actual | — | 2020-07-07 |
| Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of AgeNCT03108625Incidence of Treatment-Emergent Adverse Events (Safety)Open-label · Treatment | Phase 3 | Completed | Drug: Vortioxetine | Depressive Disorder, Major | 94 | 2020-04-16actual | — | 2021-06-24 |
| A Study Investigating Tablet Formulations of Lu AF11167 in Healthy SubjectsNCT04104503Cmax of Lu AF11167Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF11167, [14C]-Lu AF11167, Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) | Healthy | 33 | 2020-04-09actual | — | 2020-04-17 |
| Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy SubjectsNCT04275115AUC0-infOpen-label · Treatment | Phase 1 | Completed | Drug: Drug Cocktail, Foliglurax, midazolam iv | Healthy | 20 | 2020-04-03actual | — | 2020-04-24 |
| Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)NCT04175132Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: New efficacy data from another study | Drug: foliglurax, foliglurax | Healthy, Parkinson Disease | 6 | 2020-03-03actual | — | 2020-12-09 |
| Study With Vortioxetine on Emotional Functioning in Patients With DepressionNCT03835715Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total scoreOpen-label · Treatment | Phase 4 | Completed | Drug: Vortioxetine | Major Depressive Disorder | 150 | 2020-02-21actual | — | 2020-03-24 |
| Safety and Tolerability of Lu AF95245 in Healthy Young MenNCT04199585Number of participants with treatment-emergent adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: new safety data from another study | Drug: Lu AF95245, Lu AF95245 14C radiolabelled spiked dosage, Placebo | Healthy | 18 | 2020-02-16actual | — | 2020-05-12 |
| Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With SchizophreniaNCT02892422results2020-10-26Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Lu AF35700 | Schizophrenia | 528 | 2019-10-10actual | — | 2020-10-26 |
| Single Dose of Lu AF28996 to Healthy Young MenNCT03565094AUC 0-infOpen-label · Treatment | Phase 1 | Completed | Drug: Lu AF28996 solution, Lu AF28996 capsule | Healthy | 39 | 2019-08-17actual | — | 2019-09-26 |
| What the Body Does to Foliglurax in Healthy VolunteersNCT04002895Total amount of radioactivity excretedOpen-label · Treatment | Phase 1 | Completed | Drug: Foliglurax | Healthy | 6 | 2019-08-01actual | — | 2019-11-04 |
| Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With DepressionNCT03766867Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale scoreRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Vortioxetine infusion 25 mg, Vortioxetine tablets 10 mg/day, Placebo infusion, Placebo tablets | Major Depressive Disorder | 80 | 2019-07-31actual | — | 2019-08-29 |
| Pharmacokinetics of Lu AF35700 in Subjects With Renal ImpairmentNCT03241147AUC0-infNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: New data; the study was terminated based on new efficacy data | Drug: Lu AF35700 | Renal Failure | 23 | 2019-07-17actual | — | 2019-09-30 |
| Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's DiseaseNCT02388152Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: New data: The study was terminated based on new efficacy data from another study | Drug: Lu AF20513, low dose, Lu AF20513, medium dose, Lu AF20513, high dose, Lu AF20513, double high dose | Alzheimer Disease | 50 | 2019-07-04actual | — | 2019-11-29 |
| Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)NCT02709746results2020-08-19Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After TreatmentRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20 mg/day · Other: Placebo | Depressive Disorder, Major | 784 | 2019-07-02actual | — | 2020-08-19 |
| Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to ADNCT03819699AUCRandomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: New data: The study was terminated based on new efficacy data from another study | Drug: Lu AF20513 · Biological: booster vaccine | Alzheimer Disease | 3 | 2019-06-27actual | — | 2020-02-21 |
| A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy SubjectsNCT03884491absolute bioavailability (F)Open-label · Treatment | Phase 1 | Completed | Drug: Vortioxetine IV, Vortioxetine SLA, Vortioxetine SLB, Vortioxetine SLC | Healthy | 16 | 2019-06-25actual | — | 2019-08-01 |
| A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)NCT03668405Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: New data: The study was terminated based on new efficacy data from another study | Drug: Lu AF20513 | Alzheimer's Disease | 18 | 2019-05-27actual | — | 2019-11-21 |
| Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and WomenNCT03103646AUC(0-inf)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF35700, Itraconazole (200 mg), Itraconazole (300 mg) | Cytochrome P450 Interaction | 22 | 2019-04-14actual | — | 2019-10-02 |
| A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy SubjectsNCT03826134Total distribution volumes (VT) for each region of interest (ROI)Open-label · Treatment | Early Phase 1 | Completed | Drug: [11C]PXT012253 | Parkinson Disease | 7 | 2019-03-15actual | — | 2020-02-05 |
| Single Ascending Dose Study of Lu AF76432 in Healthy Young MenNCT03531229Number of participants with Treatment-Emergent Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Placebo, Lu AF76432 | Healthy | 42 | 2019-02-22actual | — | 2019-04-12 |
| Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed ConditionsNCT03670095AUC0-72h in fed state for test and reference treatmentRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lactose-free memantine, Memantine | Healthy | 64 | 2018-12-24actual | — | 2024-02-29 |
| Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant SchizophreniaNCT03230864results2020-01-07Change From Randomization to Week 8 in Positive and Negative Syndrome Scale (PANSS) Total ScoreRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: New data; the study was terminated based on new efficacy data from another study | Drug: Lu AF35700, Risperidone, Olanzapine | Treatment-resistant Schizophrenia | 119 | 2018-12-23actual | — | 2020-01-21 |
| Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed StateNCT03670082Absolute bioavailability FabsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF35700, Lu AF35700 iv | Healthy | 10 | 2018-12-21actual | — | 2019-11-01 |
| Bioequivalence Study of Lu AF35700NCT03394482AUC0-72h of Lu AF35700Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation, Lu AF35700 10 mg commercial formulation, Lu AF35700 20 mg clinical formulation, Lu AF35700 20 mg commercial formulation | Healthy | 87 | 2018-10-05actual | — | 2018-11-29 |
| Effect of Lu AF35700 in Patients With Treatment-resistant SchizophreniaNCT02717195results2019-11-25Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total ScoreRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Risperidone, Olanzapine, Lu AF35700, Lu AF35700 | Schizophrenia | 1,098 | 2018-08-30actual | — | 2019-11-25 |
| Bioequivalence Study to Compare Two Formulations of Deanxit®NCT03472651AUC0-72h: flupentixolRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: test treatment: flupentixol/melitracen, reference treatment: flupentixol/melitracen | Healthy | 60 | 2018-06-28actual | — | 2024-02-29 |
| Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective DisorderNCT02901587Change from time-matched baseline on day 1, 21, and 42 in QTcFRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day), Quetiapine (Seroquel XR® 800 mg/day) | Schizophrenia, Schizoaffective Disorder | 119 | 2018-04-18actual | — | 2019-09-12 |
| Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy SubjectsNCT03189615Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF35700 | Hepatic Impairment | 24 | 2018-02-28actual | — | 2018-05-04 |
| Positron Emission Tomography (PET) Study in Patients With Alzheimer's DiseaseNCT033079935-HT6 Receptor Occupancy (RO)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was terminated for strategic reasons. | Drug: Idalopirdine | Alzheimer's Disease | 3 | 2018-02-19actual | — | 2018-04-04 |
| Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing EnzymesNCT03195946AUC(0-inf): Area under the plasma concentration-time curve from zero to infinityOpen-label · Treatment | Phase 1 | Completed | Drug: Lu AF35700, Midazolam, Cocktail of CYP450 substrates | Drug Reactions | 24 | 2018-01-03actual | — | 2018-01-08 |
| Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's DiseaseNCT02079246results2018-08-10Number of Treatment Emergent Adverse Events (TEAEs) in the OLEXNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Idalopirdine 60 mg | Alzheimer's Disease | 1,463 | 2017-07-06actual | — | 2018-08-10 |
| Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive DisorderNCT02919501Change from baseline to Week 1 in MADRS total scoreRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Vortioxetine (IV), Vortioxetine (tablet) · Other: Placebo (IV) | Depressive Disorder, Major | 55 | 2017-04-27actual | — | 2018-06-20 |
| Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase InhibitorNCT02006654results2018-02-07Change in CognitionRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Idalopirdine | Alzheimer's Disease | 734 | Jan 2017actual | — | 2018-02-07 |
| Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With DonepezilNCT02006641results2018-02-20Change in CognitionRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Idalopirdine | Alzheimer's Disease | 858 | Dec 2016actual | — | 2018-02-20 |
| An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease PatientsNCT02649608results2019-12-02Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: 0.04 mg Lu AE04621, 0.08 mg Lu AE04621, 0.2 mg Lu AE04621, 0.4 mg Lu AE04621, 0.6 mg Lu AE04621, 0.8 mg Lu AE04621, 1.0 mg Lu AE04621, 1.2 mg Lu AE04621 | Parkinson Disease | 15 | Dec 2016actual | — | 2021-02-24 |
| Investigating the Effect of Vortioxetine in Adult ADHD PatientsNCT02327013results2018-01-31Change in ADHD Investigator Symptom Rating Scale (AISRS) Total ScoreRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: vortioxetine 10 mg tablet, vortioxetine 20 mg tablet · Other: Placebo tablet | Attention Deficit Hyperactivity Disorder | 227 | Sep 2016actual | — | 2018-03-07 |
| Bioequivalence Study of Idalopirdine in Healthy SubjectsNCT02894515Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-doseRandomized · Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: The study was withdrawn based on new efficacy data from another study | Drug: Idalopirdine commercial tablet (test), Idalopirdine clinical tablet (reference) | Bioequivalence | 0 | Sep 2016actual | — | 2016-11-11 |
| Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With DonepezilNCT01955161results2017-09-19Change in CognitionRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Idalopirdine | Alzheimer's Disease | 933 | Jul 2016actual | — | 2017-09-19 |
| Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With AlzheimerNCT02553928results2019-03-14Adverse EventsRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Memantine (once daily), Memantine (twice daily) | Alzheimer Dementia (AD) | 62 | Jul 2016actual | — | 2019-03-14 |
| Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant TreatmentNCT01838681results2017-08-09Full Remission During the Randomised Treatment PeriodRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Brexpiprazole, ADT | Major Depressive Disorder | 1,986 | Jun 2016actual | — | 2017-08-09 |
| Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant TreatmentNCT02400346results2017-06-26Number of Patients With Treatment-Emergent Adverse EventsOpen-label · Treatment | Phase 3 | Completed | Drug: Adjunct brexpiprazole, ADT | Major Depression Disorder | 132 | Jun 2016actual | — | 2017-08-10 |
| Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol FormulationsNCT02660840The area under the plasma concentration-time curveRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment), 5 mg Flupentixol film-coated tablet (test treatment), 0.5 mg Flupentixol coated tablet (reference treatment), 1 mg Flupentixol coated tablet (reference treatment), 5 mg Flupentixol coated tablet (reference treatment) | Bioequivalence Study in Healthy Subjects | 84 | Jun 2016actual | — | 2016-07-26 |
| Comparison of the Effectiveness of Brexpiprazole With That of RisperidoneNCT02758067Change in Quality of life (QLS total score)Randomized · Double-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: This study was withdrawn for administrative reasons. There were no safety concerns. | Drug: brexpiprazole, risperidone | Schizophrenia | 0 | Jun 2016actual | — | 2016-08-01 |
| Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive DisorderNCT02279953Change in Digit Symbol Substitution Test (DSST): number of correct symbolsRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Vortioxetine 10-20 mg, Placebo, SSRI | Major Depressive Disorder | 151 | Apr 2016actual | — | 2017-05-24 |
| Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive DisorderNCT02272517Change in Digit Symbol Substitution Test (DSST)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Vortioxetine 10-20 mg, Escitalopram 10-20 mg | Major Depressive Disorder | 101 | Mar 2016actual | — | 2017-02-28 |
| Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary CareNCT02195817Change in the number of Heavy Drinking Days (HDDs) (days/month)Non-randomized · Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: The study was terminated due to enrolment challenges | Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A · Other: Initial psychosocial support: Cohort B | Alcohol Dependence | 378 | Feb 2016actual | — | 2017-02-28 |
| Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive DisorderNCT02279966Change in Digit Symbol Substitution Test (DSST): number of correct symbolsRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Vortioxetine 10 mg, Paroxetine 20 mg, Placebo | Major Depressive Disorder | 152 | Feb 2016actual | — | 2017-02-28 |
| Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700NCT02333487results2020-05-12Emax D1 DopamineNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF35700 | Schizophrenia | 22 | 2016-02-11actual | — | 2020-05-12 |
| Brexpiprazole in Patients With SchizophreniaNCT01810783results2017-02-23Safety and TolerabilityOpen-label · Treatment | Phase 3 | Completed | Drug: Brexpiprazole | Schizophrenia | 210 | Dec 2015actual | — | 2017-03-27 |
| Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed UseNCT02197598Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)Open-label · Treatment | Phase 4 | Completed | Drug: nalmefene | Alcohol Dependence | 45 | Dec 2015actual | — | 2016-12-14 |
| Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)NCT01987960results2017-03-13PTSD Symptoms Using CAPS-2 Total ScoreRandomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns | Drug: Placebo, Brexpiprazole | Post-traumatic Stress Disorder, PTSD | 417 | Oct 2015actual | — | 2017-03-13 |
| Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet SyndromeNCT02187809results2017-02-15Number of Participants With Adverse Events as a Measure of Safety and TolerabilityOpen-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: The study was terminated due to recruitment challenges | Drug: Clobazam | Dravet Syndrome | 3 | Oct 2015actual | — | 2017-03-27 |
| Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney FunctionNCT02340195Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Idalopirdine (Lu AE58054) 60 mg | Alzheimer Disease | 16 | Sep 2015actual | — | 2015-11-09 |
| Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet SyndromeNCT02174094Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary countsRandomized · Triple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: The study was terminated due to recruitment challenges | Drug: Clobazam, Placebo | Dravet Syndrome | 0 | Aug 2015actual | — | 2015-09-24 |
| Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy MenNCT02436486Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection periodRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Placebo, ldalopirdine 120 mg, Idalopirdine 360 mg, Moxifloxacin 400 mg | Healthy Volunteers | 76 | Aug 2015actual | — | 2015-09-22 |
| Investigating the Absorption, Metabolism and Excretion (AME) of IdalopirdineNCT02415907Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)Open-label · Treatment | Phase 1 | Completed | Drug: [ethyl-1-14C]-idalopirdine, [benzyl-7-14C]-idalopirdine | Healthy | 6 | Jun 2015actual | — | 2015-07-20 |
| Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and WomenNCT02386488Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratioRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Vortioxetine 10 mg single dose, Vortioxetine 20 mg single dose, Vortioxetine 10 mg multiple dose, Vortioxetine 20 mg multiple dose | Pharmacokinetics | 64 | May 2015actual | — | 2015-05-19 |
| Bioequivalence Study of Idalopirdine Tablets 60 mgNCT02371707Area under the idalopirdine plasma concentration-time curveRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Idalopirdine 60 mg formulation A (test), Idalopirdine 60 mg formulation B (reference) | Healthy | 30 | Apr 2015actual | — | 2015-05-07 |
| Aripiprazole Once-monthly in Patients With SchizophreniaNCT01959035results2016-05-16Safety and TolerabilityOpen-label · Treatment | Phase 3 | Completed | Drug: Aripiprazole once-monthly | Schizophrenia | 88 | Mar 2015actual | — | 2017-03-17 |
| Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy SubjectsNCT02231450Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AE58054 encapsulated film-coated tablets | Heptic Impairment | 24 | Mar 2015actual | — | 2015-03-18 |
| Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167NCT02260830PK parameters for Lu AF11167 estimated from the single dose treatment periods in Part A and B: Cmax, Frel, AUC0-inf, AUC0t, AUC%extr, CL/F, t½, tlag, tmax and Vz/F.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF11167 | Schizophrenia | 28 | Mar 2015actual | — | 2015-03-06 |
| A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive DisorderNCT01427439observationalPatients' functioning assessed by the Sheehan Disability Scale (SDS) total score | — | Completed | — | Major Depressive Disorder | 1,455 | Feb 2015actual | — | 2015-07-08 |
| Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.NCT02199431Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Lu AF11167, Itraconazole | Healthy | 20 | Feb 2015actual | — | 2015-09-21 |
| Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With SchizophreniaNCT02202213Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Placebo, Lu AF11167 | Schizophrenia | 47 | Feb 2015actual | — | 2015-02-18 |
| Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With SchizophreniaNCT02202226Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AF35700, Placebo | Schizophrenia | 96 | Feb 2015actual | — | 2015-03-06 |
| Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety DisorderNCT01491035results2016-01-15Cmax of VortioxetineNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Vortioxetine, Vortioxetine, Vortioxetine, Vortioxetine | Depressive Disorder, Anxiety Disorder | 48 | Dec 2014actual | — | 2017-03-16 |
| Brexpiprazole in Patients With Acute SchizophreniaNCT01810380results2016-03-29Change From Baseline to Week 6 in PANSS Total ScoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Brexpiprazole, Quetiapine extended release | Schizophrenia | 468 | Dec 2014actual | — | 2017-03-16 |
| Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male SubjectsNCT02072278Battery of EEG measurementsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Vortioxetine 10 mg, Vortioxetine 20 mg, Escitalopram 15 mg, Placebo | Healthy Men | 32 | Nov 2014actual | — | 2015-09-01 |
| Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)NCT00856661results2015-12-22Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)Randomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol | Drug: Desmoteplase, Placebo | Stroke | 270 | Oct 2014actual | — | 2017-03-16 |
| Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol ChallengeNCT01969617Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) taskRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Nalmefene 18 mg, then placebo, Placebo, then Nalmefene 18 mg | Alcohol Dependence | 22 | Oct 2014actual | — | 2014-11-11 |
| Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With SchizophreniaNCT01795547results2015-12-03Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total ScoreRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Aripiprazole and aripiprazole once-monthly, Paliperidone and paliperidone palmitate | Schizophrenia | 295 | Sep 2014actual | — | 2017-03-17 |
| Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy WomenNCT02112903Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating ScaleRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Encapsulated vortioxetine IR tablet, 20 mg, Vortioxetine MR capsule 20 mg (pH 5.5), Vortioxetine MR capsule 20 mg (pH 6.0), Vortioxetine MR capsule 20 mg (pH 7.0) | Healthy Women | 40 | Sep 2014actual | — | 2014-11-13 |
| Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy SubjectsNCT01934166For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)Open-label | Phase 1 | Completed | Drug: Nalmefene 18 mg | Renal Impairment | 32 | Aug 2014actual | — | 2016-11-08 |
| Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive DisorderNCT01942733results2016-03-01Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) ParametersOpen-label · Treatment | Phase 3 | Completed | Drug: Brexpiprazole | Sleep Disturbances | 44 | Aug 2014actual | — | 2019-03-20 |
| Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic StrokeNCT00790920Modified Rankin Scale ScoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Desmoteplase, Placebo | Stroke | 492 | Jul 2014actual | — | 2015-09-18 |
| Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant TherapyNCT01942785results2016-03-15Change From Baseline to Week 6 in SIS Total ScoreOpen-label · Treatment | Phase 3 | Completed | Drug: Brexpiprazole | Major Depressive Disorder, Irritability | 55 | Jul 2014actual | — | 2016-03-15 |
| Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)NCT02179931Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Flupentixol/melitracen film-coated tablet, Flupentixol/melitracen coated tablet (Deanxit®) | Healthy Men and Women | 30 | Jul 2014actual | — | 2014-09-04 |
| D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer CompoundNCT02093169Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time pointNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Part A: Lu AF35700, Part B: Lu AF35700 | Healthy Men | 12 | Jun 2014actual | — | 2014-09-23 |
| Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy SubjectsNCT02122692Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)Open-label · Treatment | Phase 1 | Completed | Drug: Lu AE58054 30 mg, Lu AE58054 30 mg + itraconazole 200 mg, Itraconazole | Healthy Volunteers | 20 | Jun 2014actual | — | 2014-06-19 |
| Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant TreatmentNCT01837797results2016-03-03Change From Randomisation in Depressive Symptoms During the Randomised TreatmentRandomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: The study was terminated because of recruitment challenges | Drug: Placebo, Brexpiprazole 1 mg, Brexpiprazole 3 mg | Major Depressive Disorder | 129 | May 2014actual | — | 2018-10-17 |
| Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive DisorderNCT01944969results2016-03-03Number of Participants With Treatment-Emergent Adverse EventsOpen-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: The study was terminated because the lead-in study (14571A) in elderly was terminated; see Detailed Description. | Drug: Brexpiprazole | Major Depressive Disorder | 26 | May 2014actual | — | 2018-10-17 |
| Absolute Bioavailability of Lu AE58054 in Healthy SubjectsNCT02019394Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IVOpen-label | Phase 1 | Completed | Drug: Lu AE58054 | Healthy | 10 | Feb 2014actual | — | 2014-03-21 |
| Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaNCT01556165results2014-12-23Change From Baseline to Week 26 in UPDRS Total ScoreRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: rasagiline, placebo | Parkinson's Disease | 130 | Dec 2013actual | — | 2014-12-23 |
| Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian CountriesNCT01571453results2014-10-13Change From Baseline in MADRS Total Score at Week 8Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Vortioxetine (Lu AA21004), Venlafaxine extended release | Major Depressive Disorder | 437 | Oct 2013actual | — | 2014-10-13 |
| Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian SubjectsNCT01975779Number and frequency of adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Cohort A1: Lu AE58054 or placebo, Cohort A2: Lu AE58054 or placebo, Cohort B1: Lu AE58054 | Healthy | 42 | Oct 2013actual | — | 2013-11-05 |
| Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in ControlsNCT01607125Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Vortioxetine (Lu AA21004), Placebo | Depression | 96 | Sep 2013actual | — | 2013-09-25 |
| Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in ChinaNCT01479530results2014-06-26Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient DiaryRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Azilect® | Parkinson's Disease | 321 | Jun 2013actual | — | 2018-09-10 |
| Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive DisorderNCT01422213results2014-08-05Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scoresRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Vortioxetine (Lu AA21004), Vortioxetine (Lu AA21004) | Major Depressive Disorder | 598 | May 2013actual | — | 2014-08-05 |
| A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous MedicationNCT01488071results2014-03-26Change From Baseline in MADRS Total Score at Week 8Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Vortioxetine (Lu AA21004), Agomelatine | Major Depressive Disorder | 495 | Dec 2012actual | — | 2014-03-26 |
| Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and WomenNCT01676571PK AUC determination of Lu AA21004 (Vortioxetine)Open-label · Treatment | Phase 1 | Completed | Drug: Lu AA21004 | Healthy | 16 | Nov 2012actual | — | 2013-01-16 |
| Safety and Efficacy of Zicronapine in Patients With SchizophreniaNCT01295372To assess the effect of zicronapine versus risperidone on body weight (and BMI)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Zicronapine, Risperidone | Schizophrenia | 160 | Oct 2012actual | — | 2016-11-08 |
| Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in AdultsNCT01323478results2014-02-11Number of Patients With Adverse Events (AEs)Open-label · Treatment | Phase 3 | Completed | Drug: Vortioxetine (Lu AA21004) | Major Depressive Disorder | 71 | Sep 2012actual | — | 2014-02-11 |
| Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in KoreaNCT01268891results2013-12-03Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient DiaryRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Azilect® | Parkinson's Disease | 132 | Jun 2012actual | — | 2013-12-03 |
| Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and WomenNCT01652313Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)Open-label · Treatment | Phase 1 | Completed | Drug: Rasagiline | Parkinson's Disease | 12 | Jun 2012actual | — | 2012-07-30 |
| Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With SchizophreniaNCT01377233results2016-03-22Number of Patients With Adverse Events as a Measure of Safety and TolerabilityRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Zicronapine open-label lead-in 10 mg daily, Zicronapine 10 mg daily, Zicronapine 20 mg once weekly, Zicronapine 30 mg once weekly, Zicronapine 45 mg once weekly | Schizophrenia | 46 | Feb 2012actual | — | 2016-03-22 |
| Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's DiseaseNCT01019421Change in cognition after 24 weeksRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Lu AE58054, Placebo | Alzheimer's Disease | 278 | Dec 2011actual | — | 2012-01-06 |
| Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in AdultsNCT01140906results2014-02-11Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Vortioxetine (Lu AA21004), Duloxetine | Major Depressive Disorder | 607 | Sep 2011actual | — | 2014-02-11 |
| Efficacy of Nalmefene in Patients With Alcohol DependenceNCT00812461results2013-07-09Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Nalmefene | Alcohol Dependence | 678 | Mar 2011actual | — | 2013-07-22 |
| Safety Study of Carbamylated Erythropoietin to Treat Patients With the Neurodegenerative Disorder Friedreich's AtaxiaNCT01016366To evaluate the safety and tolerability of 2 weeks treatment with Lu AA24493 in patients with Friedreich's AtaxiaRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Lu AA24493, Placebo | Friedreich's Ataxia | 36 | Mar 2011actual | — | 2016-11-08 |
| Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic StrokeNCT00870844National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AA24493 (CEPO), Placebo | Acute Ischemic Stroke | 24 | Dec 2010actual | — | 2011-04-20 |
| Safety and Efficacy of Nalmefene in Patients With Alcohol DependenceNCT00811941results2013-08-07Number of Patients With Adverse Events (AEs)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Nalmefene | Alcohol Dependence | 665 | Nov 2010actual | — | 2013-08-07 |
| Efficacy of Nalmefene in Patients With Alcohol DependenceNCT00811720results2013-07-09Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Nalmefene | Alcohol Dependence | 598 | Oct 2010actual | — | 2013-07-09 |
| Safety Study of an Antipsychotic, Sertindole, to Treat SchizophreniaNCT00763438All serious adverse events reported; visits scheduled every 3 monthsOpen-label · Treatment | Phase 4 | Completed | Drug: Sertindole | Schizophrenia | 18 | Jul 2010actual | — | 2016-11-08 |
| Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's DiseaseNCT00857233results2012-08-29Number of Patients With Adverse Events (AEs)Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Please see explanation in the Detailed Description field. | Drug: Memantine | Alzheimer's Disease | 297 | Jul 2010actual | — | 2012-08-29 |
| Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety DisorderNCT00788034Time to relapseRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Lu AA21004, Placebo | Generalized Anxiety Disorder | 459 | Jun 2010actual | — | 2015-06-23 |
| Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's DiseaseNCT00857649results2012-01-09Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.Randomized · Double-masked · Treatment | Phase 3 | Terminated | Drug: Memantine, Placebo | Alzheimer's Disease | 369 | Apr 2010actual | — | 2013-12-05 |
| Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in AdultsNCT00694304results2014-04-01Number of Patients With Adverse Events (AEs)Open-label · Treatment | Phase 3 | Completed | Drug: Vortioxetine (Lu AA21004) | Major Depressive Disorder | 535 | Mar 2010actual | — | 2014-04-01 |
| Bioequivalence Study Comparing Two Formulations of EscitalopramNCT01395433To show bioequivalence on the basis of the area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of two different dosage forms of escitalopramRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Escitalopram, Escitalopram, Escitalopram | Healthy | 32 | Mar 2010actual | — | 2012-12-10 |
| Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly PatientsNCT00811252results2013-12-18Change From Baseline in HAM-D-24 Total Score After 8 Weeks of TreatmentRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Vortioxetine (Lu AA21004), Duloxetine | Major Depressive Disorder | 453 | Feb 2010actual | — | 2014-01-29 |
| Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With SchizophreniaNCT00654706Neurocognitive effect of treatment based on the overall composite score on the MCCBRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Sertindole, Quetiapine | Schizophrenia, Cognition | 264 | Jan 2010actual | — | 2014-05-28 |
| Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With SchizophreniaNCT00810667Efficacy effect of treatment based on the PANSS total scoreRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Lu AE58054, Placebo | Schizophrenia, Cognition | 124 | Jan 2010actual | — | 2016-11-08 |
| Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive DisorderNCT00807248results2011-08-11Montgomery and Åsberg Depression Rating Scale (MADRS)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Escitalopram placebo, Gaboxadol placebo, Escitalopram 20 mg, Gaboxadol 5 mg, Gaboxadol 10 mg | Major Depressive Disorder | 490 | Dec 2009actual | — | 2012-12-17 |
| Escitalopram in Patients With Social Anxiety DisorderNCT00902226results2011-06-10Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)Open-label · Treatment | Phase 4 | Completed | Drug: Escitalopram | Social Anxiety Disorder | 30 | Dec 2009actual | — | 2011-06-10 |
| Escitalopram in Patients With Generalized Anxiety DisorderNCT00902564results2011-06-10Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)Open-label · Treatment | Phase 4 | Completed | Drug: Escitalopram | Generalized Anxiety Disorder | 30 | Dec 2009actual | — | 2011-06-10 |
| Efficacy of Lu 31-130 in Patients With SchizophreniaNCT00768326Safety: Adverse events, clinical safety laboratory tests (including liver biochemistry tests), metabolic parameters (including blood lipids, blood glucose weight, waist circumference), abnormal movementsRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Zicronapine, Zicronapine, Zicronapine, Zicronapine, Zicronapine, Placebo | Schizophrenia | 280 | Oct 2009actual | — | 2016-11-08 |
| Efficacy of Lu 31-130 in Patients With SchizophreniaNCT00770744Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Zicronapine, Olanzapine | Schizophrenia | 93 | Oct 2009actual | — | 2016-11-08 |
| Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive EpisodesNCT00596817results2014-03-31Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the InvestigatorRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Vortioxetine (Lu AA21004) | Major Depressive Disorder | 639 | Sep 2009actual | — | 2014-03-31 |
| Efficacy of Bifeprunox in Patients With SchizophreniaNCT00658645The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).Randomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Interim analysis showed inadequate efficacy of bifeprunox | Drug: Bifeprunox, Placebo, Quetiapine | Schizophrenia | 227 | Aug 2009actual | — | 2010-09-27 |
| Efficacy of Bifeprunox in Patients With SchizophreniaNCT00704509The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).Randomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Interim analysis showed inadequate efficacy of bifeprunox | Drug: Bifeprunox, Placebo, Quetiapine | Schizophrenia | 346 | Aug 2009actual | — | 2010-09-27 |
| Efficacy and Safety of Lu AA39959 in Patients With Bipolar DepressionNCT00771134Depressive symptoms as measured by the change from baseline in total MADRS scoreRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Study was previously suspended and is now terminated | Drug: Lu AA39959, Placebo, Quetiapine | Bipolar Disorder | 105 | Jun 2009actual | — | 2014-05-28 |
| Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive DisorderNCT00635219results2014-02-11Change From Baseline in MADRS Total Score After 8 Weeks of TreatmentRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Vortioxetine (Lu AA21004), Vortioxetine (Lu AA21004), Vortioxetine (Lu AA21004), Duloxetine | Major Depressive Disorder | 766 | Apr 2009actual | — | 2014-02-11 |
| Dose-finding Study With Lu AA24530 in Major Depressive DisorderNCT00599911The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total scoreRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Lu AA24530, Duloxetine, Placebo | Major Depressive Disorder | 652 | Mar 2009actual | — | 2016-11-08 |
| A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's DiseaseNCT00862940results2011-06-03Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Memantine, Placebo | Alzheimer's Disease | 277 | Feb 2009actual | — | 2012-09-03 |
| Efficacy and Safety of Lu AA34893 in Patients With Bipolar DepressionNCT00622245Depressive symptoms as measured by the change from baseline in total MADRS scoreRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Human metabolite not yet covered sufficiently by nonclinical data | Drug: Lu AA34893, Quetiapine fumarate, Placebo | Depression in Patients With Bipolar Disorder | 166 | Jan 2009actual | — | 2010-09-27 |
| Efficacy and Safety of Lu AA34893 in Patients With Major Depressive DisorderNCT00766870Depressive symptoms as measured by the change from baseline in MADRS total scoreRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Study was previously paused and is now terminated | Drug: Lu AA34893, Venlafaxine extended release, Placebo | Major Depressive Disorder | 35 | Jan 2009actual | — | 2010-09-29 |
| Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy BodiesNCT00855686No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Memantine, Placebo | Parkinson's Disease Dementia, Dementia With Lewy Bodies | 199 | Dec 2008actual | — | 2013-09-20 |
| Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic StrokeNCT00756249National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Lu AA24493 (CEPO), Placebo | Acute Ischemic Stroke | 16 | Sep 2008actual | — | 2010-09-27 |
| Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in AdultsNCT00761306results2013-12-17Number of Patients With Adverse Events (AEs)Open-label · Treatment | Phase 2 | Completed | Drug: Vortioxetine (Lu AA21004) | Major Depressive Disorder | 74 | Sep 2008actual | — | 2014-01-29 |
| Exploratory Cognition Study of Sertindole in Patients With SchizophreniaNCT00759421Global cognitive composite scoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Sertindole, Olanzapine | Schizophrenia | 96 | Mar 2008actual | — | 2013-09-16 |
| Study on Metabolic Parameters of Sertindole in Patients With SchizophreniaNCT00759460Changes from baseline by treatment and between treatments for each of the components of the metabolic syndromeRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Sertindole, Olanzapine | Schizophrenia | 250 | Mar 2008actual | — | 2013-09-20 |
| Sertindole in Asian Patients With SchizophreniaNCT00864045To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Sertindole, Olanzapine | Schizophrenia | 394 | Mar 2008actual | — | 2013-09-20 |
| Safety Study of Sertindole Versus Risperidone Under Normal Conditions of UseNCT00856583results2011-08-01Number of Participants With All-cause MortalityRandomized · Open-label · Prevention | Phase 3 | Completed | Drug: Sertindole, Risperidone | Schizophrenia | 9,809 | Feb 2008actual | — | 2011-08-19 |
| Bifeprunox Extension to Extension Study in Patients With SchizophreniaNCT00861497Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: The study stopped after been paused (the patients were switched in the meantime) | Drug: Bifeprunox | Schizophrenia | 11 | Jan 2008actual | — | 2013-09-16 |
| Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in AdultsNCT00839423results2013-12-17Change From Baseline in MADRS Total Score After 6 Weeks of TreatmentRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Placebo, Vortioxetine (Lu AA21004), Venlafaxine XL | Major Depressive Disorder | 426 | Aug 2007actual | — | 2014-05-13 |
| Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)NCT00094666Amount of time spent awake and time to fall asleep at night after two daysRandomized · Double-masked · Treatment | Phase 3 | Terminated | Drug: MK0928, gaboxadol / Duration of Treatment - 6 weeks, Comparator: placebo / Duration of Treatment - 6 weeks | Primary Insomnia | 465 | Mar 2007actual | — | 2015-01-14 |
| Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)NCT00266357Mean of total sleep time over 2 nights.Randomized · Double-masked · Treatment | Phase 2 | Terminated | Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose), Placebo / Duration of Treatment: 2 days for screening period | Primary Insomnia | 50 | Mar 2007actual | — | 2015-01-14 |
| Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)NCT00420810Wake after sleep onset and Latency to persistent sleepRandomized · Double-masked · Treatment | Phase 3 | Terminated | Drug: MK0928 / Duration of Treatment : 8 Weeks | Primary Insomnia | 138 | Mar 2007actual | — | 2015-01-14 |
| Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)NCT00095069Patient-reported amount of sleep and time to fall sleep at night after three monthsRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: MK0928, gaboxadol / Duration of Treatment - 1 year, Comparator: placebo / Duration of Treatment -1 year | Insomnia | 600 | Feb 2007actual | — | 2015-01-14 |
| Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive DisorderNCT01148472To compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) as assessed by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at the end of 24 weeksRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Escitalopram, Duloxetine | Major Depressive Disorder | 294 | Sep 2006actual | — | 2016-11-08 |
| Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)NCT00095043Safety and tolerability after 12 months of treatmentRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: MK0928, gaboxadol, Comparator: placebo | Insomnia | 320 | Jun 2006actual | — | 2016-11-17 |
| Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)NCT00094627Amount of time spent awake and time to fall asleep at night after 2 daysRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: gaboxadol, Comparator: placebo (unspecified) | Primary Insomnia | 465 | — | — | 2015-01-14 |
| An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)NCT001021544-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerabilityRandomized · Double-masked · Treatment | Phase 3 | Withdrawn | Drug: MK0928, gaboxadol / Duration of Treatment: 10 months | Insomnia | 0 | — | — | 2015-01-14 |
| Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)NCT00102167Amount of time spent awake and time to fall asleep during one nightRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: gaboxadol | Insomnia | 663 | — | — | 2015-01-14 |
| An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)NCT00103818Patient-reported amount of sleep and time to fall asleep at night after 3 monthsRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: gaboxadol, Comparator: placebo (unspecified) | Insomnia | 900 | — | — | 2015-01-14 |
| A Study of Gaboxadol in Primary InsomniaNCT00209846SafetyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Gaboxadol | Primary Insomnia | 320 | — | — | 2007-03-30 |
| A Study of Gaboxadol in Primary InsomniaNCT00209924EfficacyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Gaboxadol | Primary Insomnia | 505 | — | — | 2007-03-30 |
| A Prospective Active-Reference Study of Gaboxadol in Primary InsomniaNCT00209937EfficacyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Gaboxadol | Primary Insomnia | 675 | — | — | 2007-03-30 |
| A Prospective Open-Label Extension Study of Gaboxadol in Primary InsomniaNCT00209950SafetyNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Gaboxadol | Primary Insomnia | 200 | — | — | 2007-03-30 |
| A Study of Gaboxadol in Primary InsomniaNCT00209963Long-term safety in gaboxadol.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Gaboxadol | Primary Insomnia | 600 | — | — | 2007-03-30 |
| MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)NCT00266344Patient-reported total sleep time.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: MK0928, gaboxadol / Duration of Treatment 3 Weeks, Placebo / Duration of Treatment 3 Weeks | Primary Insomnia | 520 | — | — | 2015-01-14 |
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