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Pitolisant shows promise for Long-Term control of idiopathic hypersomnia

NCT ID NCT05458128

First seen Jan 06, 2026 · Last updated Jun 23, 2026 · Updated 30 times

Summary

This study looks at the long-term safety and effectiveness of pitolisant in adults with idiopathic hypersomnia, a condition causing excessive daytime sleepiness. Participants had already completed a previous study. The goal is to see if pitolisant remains safe and helps control symptoms over time.

Disclaimer Read more

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

  • ARSM Research

    Huntersville, North Carolina, 28078, United States

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090, United States

  • Bogan Sleep Consultants

    Columbia, South Carolina, 29201, United States

  • Cedars-Sinai Medical Towers

    Los Angeles, California, 90048, United States

  • Central Texas Neurology Consultants, PA

    Round Rock, Texas, 78681, United States

  • Clayton Sleep Institute

    St Louis, Missouri, 63123, United States

  • Clinical Neurophysiology Services

    Sterling Heights, Michigan, 48314, United States

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054, United States

  • Comprehensive Sleep Medicine Associates

    Sugar Land, Texas, 77478, United States

  • Duke University School of Medicine

    Durham, North Carolina, 27705, United States

  • Florida Pediatric Research Institute

    Winter Park, Florida, 32789, United States

  • FutureSearch Trials of Neurology LP

    Austin, Texas, 78731, United States

  • Great Plains Health

    North Platte, Nebraska, 69101, United States

  • Intrepid Research, LLC

    Cincinnati, Ohio, 45245, United States

  • Lowcountry Lung Critical Care

    North Charleston, South Carolina, 29406, United States

  • Meris Clinical Research

    Brandon, Florida, 33511, United States

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718, United States

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

  • Neurotrials Research Inc.

    Atlanta, Georgia, 30328, United States

  • North Star Medical Research

    Middleburg, Ohio, 44130, United States

  • NorthShore University Health System

    Glenview, Illinois, 60026, United States

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • Northwest Houston Neurology and Sleep

    Tomball, Texas, 77375, United States

  • OSF HealthCare Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Ohio Sleep Medicine and Neuroscience Institue

    Dublin, Ohio, 43017, United States

  • Respiratory Specialists

    Wyomissing, Pennsylvania, 19610, United States

  • Sleep Dynamics

    Neptune City, New Jersey, 07753, United States

  • Sleep Medicine Specialists of California

    San Ramon, California, 94583, United States

  • St. Francis Medical Institute

    Clearwater, Florida, 33765, United States

  • St. Luke's Sleep Medicine and Research Center

    Chesterfield, Missouri, 63017, United States

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53719, United States

  • Western Michigan University Homer Stryker MD School of Medicine

    Kalamazoo, Michigan, 49008, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

pitolisant

What this could lead to

If successful, this could confirm pitolisant as a safe long-term treatment to reduce excessive daytime sleepiness and other symptoms of idiopathic hypersomnia.

What could go wrong

This is an open-label study with no placebo group, so results may be less reliable. Side effects are possible, and long-term benefits are not guaranteed.

Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence hypersomnia idiopathic hypersomnia Sleepiness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.