New hope for chronic sleepiness: phase 3 drug trial launches

NCT ID NCT07500090

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called HBS-301 to see if it can reduce symptoms of idiopathic hypersomnia, a condition causing severe daytime sleepiness, trouble waking up, and fatigue. About 248 adults with moderate to very severe symptoms will 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 measure changes in sleepiness and overall symptom severity.

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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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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence idiopathic hypersomnia

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

  • Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)

    RECRUITING

    Winter Park, Florida, 32789, United States

    Contact

  • Clinical Research of Gastonia

    RECRUITING

    Gastonia, North Carolina, 28054, United States

    Contact

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

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

  • David Kudrow, MD

    RECRUITING

    Morrisville, North Carolina, 27560, United States

    Contact

  • K2 Medical Research

    RECRUITING

    Nashville, Tennessee, 37204, United States

    Contact

    Contact

  • NeuroTrials Research Inc.

    RECRUITING

    Atlanta, Georgia, 30328, United States

    Contact

    Contact

    Contact

  • PharmDev Research Institute, LLC

    RECRUITING

    Miami, Florida, 33176, United States

    Contact

    Contact

  • Phillip Nowlin

    RECRUITING

    Stockbridge, Georgia, 30281, United States

    Contact

  • Respiratory Specialists

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

    Contact

    Contact

  • Santa Monica Clinical Trials

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact

    Contact

  • St. Luke's Hospital, Sleep Medicine and Research Center

    RECRUITING

    Chesterfield, Missouri, 63017, United States

    Contact

    Contact

  • Stern Research Partners, LLC

    RECRUITING

    Huntersville, North Carolina, 28078, United States

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

    Contact

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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