5 completed, 1 active not recruiting, 1 withdrawn. 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Active not recruiting 1, Withdrawn 1 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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(BF2.649) in Alcohol Use Disorder Treatment Pitolisant (BF2.649), Placebo - Alcohol Abuse, Nervous System | Phase 2 | Withdrawn | Bioprojet | 2016-10-01 | 2017-01-12 | |
| Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA) BF2.649, Placebo - Obstructive Sleep Apnoea, Excessive Daytime Sleepiness | Phase 2 | Completed | Bioprojet | 110 | 2010-10-01 | 2012-06-15 |
| Study to Demonstrate Cognitive Enhancing Effects of BF2.649 BF2.649, Placebo - Schizophrenia | Phase 2 | Completed | University of Texas Southwestern Medical Center | 52 | 2008-06-01 | 2019-04-23 |
| Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients Placebo, BF 2.649 5 mg, BF 2.649 10 mg - Excessive Daytime Sleepiness, Parkinson's Disease | Phase 2 | Completed | Bioprojet | 108 | 2007-10-01 | 2012-06-11 |
Disorders of Excessive Somnolence (3) · Alcohol-Induced Disorders, Nervous System (1) · Autism Spectrum Disorder (1) · Myotonic Dystrophy (1) · Parkinson Disease (1) · Prader-Willi Syndrome (1) · Schizophrenia (1) · Sleep Apnea, Obstructive (1) · Sleep Wake Disorders (1)
Bioprojet (4) · Harmony Biosciences Management, Inc. (2) · University of Texas Southwestern Medical Center (1)
France (3) · United States (3) · Canada (1) · Italy (1) · Spain (1) · United Kingdom (1)
Carol A Tamminga, MD (1) · Carsten Moeller (1) · Evelyne De Paillette, MD (1) · Olivier Bonnot, MD, Prof. (1)