Pitolisant
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
Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers
CompletedNCT02929342
Start: 2016-07-31End: 2016-08-31Updated: 2016-10-11
Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users
CompletedNCT03152123
Start: 2017-03-15End: 2017-10-23Updated: 2017-11-13
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
TerminatedNCT04026750
Start: 2019-09-15End: 2020-02-16Updated: 2021-04-02
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
TerminatedNCT04596267
Start: 2021-09-13End: 2023-02-03Updated: 2023-12-04
Phase 2
Phase 3
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
CompletedNCT01800045
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
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
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
Start: 2022-08-19End: 2025-10-01Updated: 2025-12-12
A Study of Pitolisant in Participants With Prader-Willi Syndrome
Enrolling by invitationNCT07219485
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
Target: 48Updated: 2026-08-26
Phase 4
Unknown Phase
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
NCT03433131
Updated: 2019-08-28
WAKIX® (Pitolisant) Pregnancy Registry
RecruitingNCT05536011
Start: 2021-08-24End: 2030-06-30Target: 1329Updated: 2026-06-12