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New hope for chronic sleepiness: phase 3 drug trial launches

NCT ID NCT07500090

Symptom relief Sponsor: Harmony Biosciences Management, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 5 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 248 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years. * Has EDS. * Has moderate to very severe symptoms of IH. * If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As-needed use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis is not permitted. Exclusion Criteria: * Has hypersomnia due to another medical disorder. * Has a history of pitolisant use within 5 half-lives prior to Screening. * Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled. * Has a history of moderate or severe hepatic impairment. * Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min. * Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence Fatigue idiopathic hypersomnia

As listed by the trial registrant

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

Idiopathic hypersomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    42 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • AMNDX Inc

    RECRUITING

    Markham, Ontario, M5S 3A3, Canada

  • Aayus Research

    RECRUITING

    Austin, Texas, 78731, United States

  • Abington Neurological Associates

    RECRUITING

    Abington, Pennsylvania, 19001, United States

  • Alpine Clinical Research Center, Inc.

    RECRUITING

    Boulder, Colorado, 80301, United States

  • Berks Schuylkill Respiratory Specialists

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • Bogan Sleep Consultants, LLC

    RECRUITING

    Columbia, South Carolina, 29201, United States

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

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Clinical Neuropsychology Services

    RECRUITING

    Sterling Heights, Michigan, 48314, United States

  • Clinical Research Institute Stockbridge

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Clinical Research of Gastonia

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • David Kudrow, MD

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • Delta Waves LLC

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Fort Wayne Neurological Center

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • HAS Research

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Infinity Medical Research Inc.

    RECRUITING

    East Providence, Rhode Island, 02914, United States

  • Intrepid Research

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Jodha Tishon Inc

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

  • K2 Medical Research

    RECRUITING

    Nashville, Tennessee, 37204, United States

  • Lowcountry Lung and Critical Care, PA

    RECRUITING

    Charleston, South Carolina, 29406, United States

  • Metroplex Pulmonary and Sleep Center

    RECRUITING

    McKinney, Texas, 75069, United States

  • NeuroTrials Research Inc.

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Neurology Care

    RECRUITING

    Ardmore, Oklahoma, 73401, United States

  • Neuroscience Research Center, LLC

    RECRUITING

    Canton, Ohio, 44718, United States

  • PharmDev Research Institute, LLC

    RECRUITING

    Miami, Florida, 33176, United States

  • Phoenix Medical Group LLC

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Revive Research Institute

    RECRUITING

    Southfield, Michigan, 48975, United States

  • Santa Monica Clinical Trials

    RECRUITING

    Santa Monica, California, 90404, United States

  • Sleep Disorders Center of Alabama

    RECRUITING

    Birmingham, Alabama, 35213, United States

  • Sleep Practitioners, LLC

    RECRUITING

    Macon, Georgia, 31210, United States

  • Sleep Therapy and Research Center

    RECRUITING

    San Antonio, Texas, 30328, United States

  • Southeast Lung Associates Research

    RECRUITING

    Rincon, Georgia, 31326, United States

  • Southwest Family Medicine Associates

    RECRUITING

    Dallas, Texas, 75235, United States

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

    RECRUITING

    Chesterfield, Missouri, 63017, United States

    Contact Email: •••••@•••••

  • Stanford Center for Sleep Medicine

    RECRUITING

    Redwood City, California, 94063, United States

  • Stern Research Partners, LLC

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Suburban Research Associates

    RECRUITING

    West Chester, Pennsylvania, 19380, United States

  • TPMG Clinical Research

    RECRUITING

    Williamsburg, Virginia, 23188, United States

  • Trial Site Solutions

    RECRUITING

    San Ramon, California, 04583, United States

  • Tricoastal Narcolepsy and Sleep Disorders Center

    RECRUITING

    Sugar Land, Texas, 77478, United States

    Contact Email: •••••@•••••

  • University of Washington

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Washington State University Sleep and Performance Center

    RECRUITING

    Spokane, Washington, 99210, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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