HomeTrialNCT06366464
🔬NCT06366464Phase 3RECRUITING

A Study of Pitolisant in Patients With Prader-Willi Syndrome

Study Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment134 participants
Primary Completion
Lead SponsorHarmony Biosciences Management, Inc.
Data Retrieved2026-04-11 04:15:56.573703+00:00
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