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A Study of Pitolisant in Patients with Prader-Willi Syndrome

Researching Pitolisant for Prader-Willi Syndrome patients.

Recruiting
6 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

Study on Pitolisant for Prader-Willi Syndrome (PWS) Patients

This study tests a drug called pitolisant to see if it helps with excessive daytime sleepiness (EDS) in people with Prader-Willi Syndrome (PWS). EDS means feeling very sleepy during the day. The study also looks at how pitolisant affects behaviors like being irritable, overeating (called hyperphagia), and other behavior problems.

The study is in several parts: a Screening Period (up to 45 days), a Double-Blind Treatment Period where neither patient nor doctor knows if they are getting pitolisant or a fake pill (placebo), and an optional Open-Label Extension Period where everyone gets pitolisant, if they choose.

  • The study involves several in-person visits over about one year.
  • Participants must have PWS and EDS and have a caregiver to help with the study.
  • Participants cannot join if they have uncontrolled sleep apnea or are in another study.

Consider joining if you meet the criteria and are interested in helping researchers learn more about treating PWS symptoms.

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Study details
    Prader-Willi Syndrome

NCT06366464

Harmony Biosciences Management, Inc.

1 March 2025

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