14 completed, 1 enrolling by invitation, 1 recruiting, 1 withdrawn. 17 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 14, Enrolling by invitation 1, Recruiting 1, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS BF2.649, Placebo - Obstructive Sleep Apnea, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 244 | 2011-08-01 | 2015-01-21 |
| Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) BF2.649 - Narcolepsy, Cataplexy | Phase 3 | Completed | Bioprojet | 102 | 2011-05-01 | 2017-01-31 |
| Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. BF2.649, Vigil, palcebo - Treatment of Excessive Daytime Sleepiness in Narcolepsy | Phase 3 | Completed | Bioprojet | 180 | 2010-11-01 | 2017-01-31 |
| Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease BF2.649 (Pitolisant) - Parkinson's Disease | Phase 3 | Completed | Bioprojet | 273 | 2010-03-01 | 2013-04-12 |
| Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease BF2.649 (pitolisant) - Parkinson's Disease | Phase 3 | Completed | Bioprojet | 268 | 2009-12-01 | 2013-04-12 |
| Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy BF2.649, BF2.649 add on Modafinil - Narcolepsy, Cataplexy | Phase 3 | Completed | Bioprojet | 14 | 2009-10-01 | 2013-02-11 |
| Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy BF2.649, Modafinil, Placebo - Narcolepsy, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 110 | 2009-05-01 | 2012-06-11 |
| Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness Pitolisant (BF2.649), Placebo Oral Tablet - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 3 | Withdrawn | Bioprojet | 2017-11-24 |
Disorders of Excessive Somnolence (13) · Narcolepsy (7) · Cataplexy (5) · Sleep Apnea, Obstructive (4) · Sleep Wake Disorders (4) · Parkinson Disease (2) · Prader-Willi Syndrome (2) · Idiopathic Hypersomnia (1) · Problem Behavior (1) · Sleepiness (1)
Bioprojet (13) · Harmony Biosciences Management, Inc. (3) · Citrine Medicine Limited (1)
France (9) · United States (3) · Germany (2) · Italy (2) · Switzerland (2) · Australia (1) · Belgium (1) · Bulgaria (1) · Canada (1) · China (1) · Denmark (1) · Finland (1) · Hungary (1) · Netherlands (1) · North Macedonia (1)
Kati Gutierrez, PharmD (3) · Claudio Bassetti (2) · Evelyne De Paillette, MD (2) · David Seiden, MD (1) · Evelyne De Paillette, Dr (1) · Giuseppe Plazzi, MD (1)
PMID 34822113, PMID 34935103, PMID 37979718, PMID 24107292, PMID 28129985, PMID 31917607, PMID 33121980, PMID 36931805
2008 (2), 2009 (2), 2016 (1)