A Study of Pitolisant in Participants With Prader-Willi Syndrome

NCT07219485 ↗

Phase 3 Enrolling by invitation 150 enrolled Harmony Biosciences Management, Inc.

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2025-08-20
Primary completion: 2030-08
Completion: 2030-08

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pitolisant	Small molecule	4.45 mg	Oral
Subject	Pitolisant	Small molecule	17.8 mg	Oral

A Study of Pitolisant in Participants With Prader-Willi Syndrome

Summary

Timeline

Drugs

Indications