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A Study of Pitolisant in Participants With Prader-Willi Syndrome

NCT07219485 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Pitolisant

* Pitolisant 4.45 mg tablets * Pitolisant 17.8 mg tablets

Sponsors & Collaborators

  • Harmony Biosciences Management, Inc.

    lead INDUSTRY

Principal Investigators

  • David Seiden, MD · Harmony Biosciences Management, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2030-08-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219485 on ClinicalTrials.gov