Active, not recruitingPhase 2NCT04257929

A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension

Studying Prader-Willi syndrome

Last synced from ClinicalTrials.gov May 7, 2026

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Key facts

Sponsor: Harmony Biosciences Management, Inc.
Intervention: Pitolisant oral tablets(drug)
Enrollment: 65 enrolled
Eligibility: 6-65 years · All sexes
Timeline: 2020 – 2028

Study locations (13)

Rady Children's Hospital - San Diego, San Diego, California, United States
Sleep Medicine Specialists of California, San Ramon, California, United States
Santa Monica Clinical Trials, Santa Monica, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Nemours Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
University of Florida College of Medicine, Gainesville, Florida, United States
Ann and Robert H Lurie Children's Hospital, Chicago, Illinois, United States
Johns Hopkins School of Medicine, Baltimore, Maryland, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
CTI, Cincinnati, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Children's Hospital/Baylor College of Medicine, Houston, Texas, United States
Road Runner Research, San Antonio, Texas, United States

Primary source

Recruitment status, site addresses, contacts, and full eligibility criteria can change between syncs. Always verify with the trial team before planning travel or treatment.

Open NCT04257929 on ClinicalTrials.gov

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