New pill aims to tame Narcolepsy's sleep attacks and sudden muscle weakness

NCT ID NCT07675135

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether HBS-301 (pitolisant) can reduce excessive daytime sleepiness and cataplexy (sudden muscle weakness) in adults with narcolepsy. Participants receive either the drug or a placebo for several weeks, followed by an open-label phase where everyone gets the drug. The goal is to see if HBS-301 improves wakefulness and quality of life.

What this could mean

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

Active substance

HBS-301 (pitolisant delayed-release)

What this could lead to

If successful, HBS-301 could offer a new treatment option to reduce daytime sleepiness and cataplexy attacks in people with narcolepsy.

What could go wrong

This is a phase 3 trial, but results may not confirm benefit over placebo. Side effects or lack of effectiveness could limit its use.

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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Conditions

The condition(s) this trial relates to.

Cataplexy Ehlers-Danlos syndrome Fatigue narcolepsy narcolepsy 1 narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Alpine Clinical Research Center, Inc

    RECRUITING

    Boulder, Colorado, 80301, United States

    Contact

  • Bogan Sleep Consultants, LLC

    RECRUITING

    Columbia, South Carolina, 29201, United States

    Contact

  • Central Florida Pediatric Sleep Disorders Institute

    RECRUITING

    Winter Park, Florida, 32789, United States

    Contact

  • Intrepid Research, LLC

    RECRUITING

    Cincinnati, Ohio, 45245, United States

    Contact

  • Lowcountry Lung and Critical Care PA

    RECRUITING

    Charleston, South Carolina, 29406, United States

    Contact

  • Neurotrials Research Inc

    RECRUITING

    Atlanta, Georgia, 30328, United States

    Contact Phone: •••-•••-••••

  • PharmaDev Clinical Research Institute, LLC

    RECRUITING

    Miami, Florida, 33176, United States

    Contact

  • Phoenix Medical Group, PC

    RECRUITING

    Peoria, Arizona, 85381, United States

    Contact

  • Respiratory Specialists

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

    Contact

  • Santa Monica Clinical Trials

    RECRUITING

    Los Angeles, California, 90025, United States

    Contact

  • Sleep Practitioners, LLC

    RECRUITING

    Macon, Georgia, 31210, United States

    Contact

  • Sleep Therapy & Research Center

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact

  • Sleep and Performance Research Center

    RECRUITING

    Spokane, Washington, 99202, United States

    Contact

  • Southwest Family Medicine

    RECRUITING

    Dallas, Texas, 75235, United States

    Contact