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A Study of Pitolisant in Participants With Prader-Willi Syndrome

NCT07219485 on ClinicalTrials.gov

Study listings come from ClinicalTrials.gov, where sponsors register and update their own studies. A listing does not mean a study is safe or effective, and DatenUS does not recommend any study. Talk with your doctor before joining a clinical trial, and use ClinicalTrials.gov for contact details and full eligibility rules.

Status
Enrolling by invitation
Phase
Phase 3
Interventional
Planned enrollment
150
Participants, all sites
U.S. sites
1
In 1 state

Study details

Conditions
Prader-Willi Syndrome
Sponsor
Harmony Biosciences Management, Inc. (Industry)
Ages
7 years and older
Sex
All
Healthy volunteers
Not accepted
Start
08/20/2025
Primary completion (expected)
August 2030
Last updated by sponsor
03/17/2026

Full eligibility rules, contacts and site names: NCT07219485 on ClinicalTrials.gov

Where the study has sites

Cities with at least one listed U.S. site. Some sites may not be enrolling yet.

  • North Carolina: Morrisville

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Frequently asked questions

What does recruiting mean?
Recruiting means the study is currently enrolling participants. Not yet recruiting means it has been registered but has not started enrolling. Enrolling by invitation means participants are selected by the study team rather than through open enrollment.
How do I join a clinical trial?
Read the full eligibility criteria and contact information on ClinicalTrials.gov, then talk with your doctor about whether a study may be right for you. The study team decides who can enroll.

Source: ClinicalTrials.gov, National Library of Medicine · Last updated 03/17/2026