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Study identifier: NCT04257929 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Completed

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

Condition: Prader-Willi Syndrome  ·  Sponsor: Harmony Biosciences Management, Inc.

PhasePhase 2
Planned participants65
Who can joinAll sexes, 6 Years to 65 Years
Healthy volunteersNo

About this study

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Prader Willi syndrome (PWS) ages 6 to 65 years.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (13)

Rady Children's Hospital - San DiegoSan Diego, California, United States
Sleep Medicine Specialists of CaliforniaSan Ramon, California, United States
Santa Monica Clinical TrialsSanta Monica, California, United States
Children's Hospital ColoradoAurora, Colorado, United States
Nemours Alfred I duPont Hospital for ChildrenWilmington, Delaware, United States
University of Florida College of MedicineGainesville, Florida, United States
Ann and Robert H Lurie Children's HospitalChicago, Illinois, United States
Johns Hopkins School of MedicineBaltimore, Maryland, United States
University of Nebraska Medical CenterOmaha, Nebraska, United States
CTICincinnati, Ohio, United States
Vanderbilt University Medical CenterNashville, Tennessee, United States
Texas Children's Hospital/Baylor College of MedicineHouston, Texas, United States

+ 1 more locations — full list on the registry record.

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