New hope for daytime sleepiness in Prader-Willi syndrome?

NCT ID NCT04257929

First seen Nov 01, 2025 · Last updated May 12, 2026 · Updated 29 times

Summary

This study tests a drug called pitolisant to see if it can safely reduce severe daytime sleepiness in people with Prader-Willi syndrome, a genetic condition. About 65 participants aged 6 to 65 will receive either pitolisant or a placebo for 11 weeks, followed by an open-label phase where everyone gets the drug. The main goal is to measure changes in sleepiness using a standard questionnaire.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Ann and Robert H Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • CTI

    Cincinnati, Ohio, 45212, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21205, United States

  • Nemours Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • Road Runner Research

    San Antonio, Texas, 78249, United States

  • Santa Monica Clinical Trials

    Santa Monica, California, 90404, United States

  • Sleep Medicine Specialists of California

    San Ramon, California, 94583, United States

  • Texas Children's Hospital/Baylor College of Medicine

    Houston, Texas, 77030, United States

  • University of Florida College of Medicine

    Gainesville, Florida, 32608, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

Conditions

Explore the condition pages connected to this study.