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A Study of Pitolisant in Patients With Prader-Willi Syndrome

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jul 2026 → Apr 2027
See other at-risk trials from Harmony Biosciences Management, Inc.

Record History

  1. Primary completion pushed from Jul 2026 to Apr 2027
    • Trial sites expanded: 54 → 57 locations
    • Study completion pushed from Jul 2027 to Apr 2028
    v17
  2. Study sites: 56 to 54v16
  3. Study sites: 58 to 56v15
  4. Site details revised at 6 of 58 sitesv14
  5. Site details revised at 7 of 58 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 34 to 58v12
  2. Study sites: 22 to 34v11
  3. Site details revised at 22 of 22 sitesv10
  4. Study sites: 17 to 22v9
  5. Study sites: 16 to 17v8
  6. Site details revised at 15 of 16 sitesv7
  7. Start date: Apr 30, 2024 to May 28, 2024
    • Site details revised at 1 of 16 sites
    v6
  8. Site details revised at 4 of 16 sitesv5
  9. Study sites: 7 to 16v4
  10. Study sites: 3 to 7v3
  11. Study sites: 2 to 3
    • Start date changed from estimate of Apr 2024 to Apr 30, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06366464
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions
(from sponsor)		 Prader-Willi Syndrome
Related terms Disorders of Excessive Somnolence, Prader-Willi Syndrome, Problem Behavior
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov