Clinical Trial

A Study of Pitolisant in Participants With Prader-Willi Syndrome

Enrolling by Invitation Phase 3
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Summary
The purpose of this study is to assess safety of pitolisant in eligible participants with Prader-Willi syndrome (PWS) who completed the End of Treatment (EOT) visit in a parent study (HBS-101-CL-002 \[Open Label Extension (OLE)\], HBS- 101-CL-004, or HBS-101-CL-312 OLE).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-10-20.
Trial Details
NCT Number NCT07219485
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions Prader-Willi Syndrome
Enrollment 150 participants
Start Date 2025-08-20
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-17