At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
Pitolisant oral tablets +1 moredrug
Likely dose
Pitolisant oral tablets 4.45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
In Brief
A Phase 2 clinical trial evaluating Pitolisant oral tablets and Placebo oral tablet for Prader-Willi Syndrome. Completed, enrolled 65 participants across 13 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Prader Willi syndrome (PWS) ages 6 to 65 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartDec 2020
Primary CompletionAug 2022
Study CompletionJan 2026
TodayJul 2026
First PostedFeb 6, 2020
Enrollment StartDec 9, 2020
Primary CompletionAug 17, 2022
Study CompletionJan 21, 2026
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.4 years ago
Interventions
Pitolisant oral tabletsdrug
Pitolisant 4.45 mg or 17.8 mg tablets
Placebo oral tabletdrug
Matching placebo tablets