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Pitolisant

DRUG14 trials

Sponsors

Harmony Biosciences Management Inc., Bioprojet, Harmony Biosciences Management, Inc., High Point Clinical Trials Center, Boston Medical Center

Conditions

Alcohol DrinkingAlcohol Use DisorderAutism Spectrum DisorderDrug AbuseExcessive Daytime SleepinessHealthyHealthy VolunteersHypoglycemia

Phase 1

Phase 2

Phase 3

Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
CompletedNCT01800045
BioprojetExcessive Daytime Sleepiness, Narcolepsy With Cataplexy
Start: 2013-04-30End: 2015-01-31Updated: 2016-08-31
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
CompletedNCT02611687
BioprojetNarcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Start: 2016-06-06End: 2025-06-05Updated: 2025-06-26
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
CompletedNCT05223166
Citrine Medicine LimitedExcessive Daytime Sleepiness
Start: 2022-04-12End: 2023-07-18Updated: 2023-07-20
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
CompletedNCT05458128
Harmony Biosciences Management, Inc.Excessive Daytime Sleepiness, Idiopathic Hypersomnia
Start: 2022-08-19End: 2025-10-01Updated: 2025-12-12
A Study of Pitolisant in Participants With Prader-Willi Syndrome
Enrolling by invitationNCT07219485
Harmony Biosciences Management, Inc.Prader-Willi Syndrome
Start: 2025-08-20End: 2030-08-01Target: 150Updated: 2026-03-17
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension
Not yet recruitingCTIS2025-523821-17-00
Harmony Biosciences Management Inc.narcolepsy
Target: 48Updated: 2026-08-26

Phase 4

Unknown Phase

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