23 completed, 2 recruiting, 2 terminated, 2 withdrawn. 17 Phase 3, 7 Phase 2, 5 Phase 1, 1 Not applicable, 1 Phase 4.
Follow pitolisant: new trials by email Literature Review of pitolisant trials Research Report on pitolisant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Pitolisant in Participants With Prader-Willi Syndrome Pitolisant - Prader-Willi Syndrome | Phase 3 | Enrolling by invitation | Harmony Biosciences Management, Inc. | 150 | 2025-08-20 | 2026-03-17 |
| A Study of Pitolisant in Patients With Prader-Willi Syndrome Pitolisant tablet, Placebo tablet - Prader-Willi Syndrome | Phase 3 | Recruiting | Harmony Biosciences Management, Inc. | 134 | 2024-05-28 | 2026-08-25 |
| Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents Pitolisant, Placebo - Autism Spectrum Disorder | Phase 2 | Active not recruiting | Bioprojet | 62 | 2023-12-20 | 2025-10-02 |
| Pitolisant Effects on Affect and Cognition Exploratory Study (PEACE Study) Pitolisant 17.8 MG [Wakix], Placebo - Anhedonia, Cognitive Function | Not applicable | Completed | University of Oxford | 58 | 2023-04-01 | 2024-05-14 |
| Pitolisant in Refractory Restless Legs Syndrome Pitolisant - Restless Legs Syndrome | Phase 4 | Unknown | William Ondo, MD | 18 | 2022-09-20 | 2022-10-14 |
| A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia Pitolisant - Idiopathic Hypersomnia, Excessive Daytime Sleepiness | Phase 3 | Completed | Harmony Biosciences Management, Inc. | 119 | 2022-08-19 | 2025-12-12 |
| A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA Pitolisant, Placebo oral tablet - Excessive Daytime Sleepiness | Phase 3 | Completed | Citrine Medicine Limited | 240 | 2022-04-12 | 2023-07-20 |
| Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Pitolisant, Placebo - Alcohol Use Disorder, Alcohol Drinking | Phase 1 | Terminated | Boston Medical Center | 9 | 2021-09-13 | 2023-12-04 |
| WAKIX® (Pitolisant) Pregnancy Registry Pitolisant, Comparator Products - Pregnancy Related, Narcolepsy | Recruiting | Harmony Biosciences Management, Inc. | 1329 | 2021-08-24 | 2026-06-12 | |
| Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1 Pitolisant Oral Tablet, Placebo oral tablet - Myotonic Dystrophy 1, Excessive Daytime Sleepiness | Phase 2 | Completed | Harmony Biosciences Management, Inc. | 30 | 2021-06-28 | 2026-09-04 |
| A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension Pitolisant oral tablets, Placebo oral tablet - Prader-Willi Syndrome | Phase 2 | Completed | Harmony Biosciences Management, Inc. | 65 | 2020-12-09 | 2026-05-12 |
| Insulin Tolerance Test Study in Patients With Type 1 Diabetes Pitolisant - Type 1 Diabetes, Hypoglycemia | Phase 1 | Terminated | High Point Clinical Trials Center | 5 | 2019-09-15 | 2021-04-02 |
| Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users Pitolisant, Placebos, Phentermine - Healthy, Drug Abuse | Phase 1 | Completed | Bioprojet | 43 | 2017-03-15 | 2017-11-13 |
| A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment Pitolisant (BF2.649), Placebo - Alcohol Abuse, Nervous System | Phase 2 | Withdrawn | Bioprojet | 2016-10-01 | 2017-01-12 | |
| Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers Pitolisant, [14C]-Pitolisant - Healthy Volunteers | Phase 1 | Completed | Bioprojet | 8 | 2016-07-01 | 2016-10-11 |
| Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period pitolisant, Placebo - Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy | Phase 3 | Completed | Bioprojet | 110 | 2016-06-06 | 2025-06-26 |
| Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA Pitolisant (BF2.649), Placebo - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 3 | Completed | Bioprojet | 389 | 2016-04-01 | 2020-07-08 |
| Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) Pitolisant, Placebo - Narcolepsy With Cataplexy, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 103 | 2013-04-01 | 2016-08-31 |
| Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) BF2.649 - Narcolepsy | Phase 3 | Completed | Bioprojet | 51 | 2012-09-01 | 2015-11-18 |
| BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. BF2.649, Placebo - Obstructive Sleep Apnea, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 268 | 2011-10-01 | 2015-01-21 |
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Disorders of Excessive Somnolence (16) · Narcolepsy (9) · Cataplexy (5) · Sleep Apnea, Obstructive (5) · Sleep Wake Disorders (5) · Parkinson Disease (3) · Prader-Willi Syndrome (3) · Alcohol Drinking (1) · Alcohol-Induced Disorders, Nervous System (1) · Alcoholism (1) · Anhedonia (1) · Autism Spectrum Disorder (1) · Diabetes Mellitus, Type 1 (1) · Hypoglycemia (1) · Idiopathic Hypersomnia (1)
Bioprojet (20) · Harmony Biosciences Management, Inc. (7) · Boston Medical Center (1) · Citrine Medicine Limited (1) · High Point Clinical Trials Center (1) · University of Oxford (1) · University of Texas Southwestern Medical Center (1) · William Ondo, MD (1)
France (13) · United States (11) · Canada (3) · Italy (3) · United Kingdom (3) · Germany (2) · Spain (2) · Switzerland (2) · Australia (1) · Belgium (1) · Bulgaria (1) · China (1) · Denmark (1) · Finland (1) · Hungary (1)
Evelyne De Paillette, MD (3) · Kati Gutierrez, PharmD (3) · Claudio Bassetti (2) · Carol A Tamminga, MD (1) · Carsten Moeller (1) · David Seiden, MD (1) · Eric Devine, PhD (1) · Evelyne De Paillette, Dr (1) · Giuseppe Plazzi, MD (1) · Litza McKenzie, MD (1) · Melanie Fein, MD (1)
PMID 34822113, PMID 34935103, PMID 37979718, PMID 24107292, PMID 28129985, PMID 31626696, PMID 31917607, PMID 33121980, PMID 36790141, PMID 36931805, PMID 40605372
2008 (2), 2009 (2), 2016 (2), R21AA028864 (1)