14 completed. 14 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 14 |
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 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 |
Disorders of Excessive Somnolence (11) · Narcolepsy (7) · Cataplexy (5) · Sleep Wake Disorders (4) · Sleep Apnea, Obstructive (3) · Parkinson Disease (2) · Idiopathic Hypersomnia (1) · Sleepiness (1)
Bioprojet (12) · Citrine Medicine Limited (1) · Harmony Biosciences Management, Inc. (1)
France (7) · Switzerland (2) · Bulgaria (1) · China (1) · Finland (1) · Germany (1) · Hungary (1) · Italy (1) · Netherlands (1) · North Macedonia (1) · Russia (1) · United States (1)
Kati Gutierrez, PharmD (3) · Claudio Bassetti (2) · Evelyne De Paillette, MD (2) · 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)