Condition: Prader-Willi Syndrome · Sponsor: Harmony Biosciences Management, Inc.
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech
This description comes directly from the study's public registry record.
Ann Adee · 773-383-6258 · clinicaltrials@harmonybiosciences.com
Linnea Ryan · clinicaltrials@harmonybiosciences.com
Always discuss trial participation with your own doctor first.
| Santa Monica Clinical Trials | Los Angeles, California, United States | Recruiting |
| Center of Excellence in Diabetes and Endocrinology | Sacramento, California, United States | Recruiting |
| Rady Children's Hospital - Scan Diego | San Diego, California, United States | Recruiting |
| Colorado Children's Hospital | Aurora, Colorado, United States | Recruiting |
| Nemours Children's Hospital | Wilmington, Delaware, United States | Recruiting |
| Atlanta Diabetes Associates | Atlanta, Georgia, United States | Withdrawn |
| Emory University School of Medicine | Atlanta, Georgia, United States | Recruiting |
| Rare Disease Research | Atlanta, Georgia, United States | Withdrawn |
| Ann And Robert H Lurie Children's Hospital of Chicago | Chicago, Illinois, United States | Recruiting |
| Riley Children's Hospital | Indianapolis, Indiana, United States | Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | Recruiting |
| Mayo Clinic-PPDS | Rochester, Minnesota, United States | Recruiting |
+ 42 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06366464