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

NCT ID NCT07675135

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Aug 28, 2026 · Updated 5 times

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.

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 258 people

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

Started

Jun 2026

Expected to finish

Nov 2027

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 NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years. * Has EDS. * 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 (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) 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 (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening). * Has any history of bipolar disorder or psychosis * Has acute or chronic liver disease or a history of moderate or severe hepatic impairment. * Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min. * Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).

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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.

Cataplexy EDS Fatigue Narcolepsy

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

    53 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

  • Clinical Neurophysiology 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

  • Delta Waves LLC

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Florida Pediatric Sleep Disorders Institute

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Fort Wayne Neurological Center

    NOT_YET_RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Geisinger Medical Center

    NOT_YET_RECRUITING

    Danville, Pennsylvania, 17821, United States

  • HasResearch

    NOT_YET_RECRUITING

    San Antonio, Texas, 78240, United States

  • Henry Ford Medical Center

    NOT_YET_RECRUITING

    Novi, Michigan, 48377, United States

  • Infinity Medical Research Inc

    NOT_YET_RECRUITING

    East Providence, Rhode Island, 02914, United States

  • Intrepid Research, LLC

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Jodha Tishon Inc

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

  • K2 Medical Research - Nashville

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37204, United States

  • Lowcountry Lung and Critical Care PA

    RECRUITING

    Charleston, South Carolina, 29406, United States

  • Medical University of South Carolina

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Metroplex Pulmonary and Sleep Center

    NOT_YET_RECRUITING

    McKinney, Texas, 75069, United States

  • Neurology Care

    NOT_YET_RECRUITING

    Ardmore, Oklahoma, 73401, United States

  • Neurotrials Research Inc

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • NorthShore University HealthSystem

    NOT_YET_RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwell Health Physician Partners

    NOT_YET_RECRUITING

    New Hyde Park, New York, 11042, United States

  • OSF St Francis Medical Center

    NOT_YET_RECRUITING

    Peoria, Illinois, 61606, United States

  • Patient First MD

    NOT_YET_RECRUITING

    Middletown, New Jersey, 07748, United States

  • PharmaDev Clinical Research Institute, LLC

    RECRUITING

    Miami, Florida, 33176, United States

  • Phoenix Medical Group, PC

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Research Carolina Elite LLC

    NOT_YET_RECRUITING

    Denver, North Carolina, 28037, United States

  • Revive Research Institute, Inc

    RECRUITING

    Southfield, Michigan, 48075, United States

  • Santa Monica Clinical Trials

    RECRUITING

    Los Angeles, California, 90025, United States

  • Sleep Disorders Center of Alabama

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35213, United States

  • Sleep Practitioners, LLC

    RECRUITING

    Macon, Georgia, 31210, United States

  • Sleep Therapy & Research Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sleep and Performance Research Center

    RECRUITING

    Spokane, Washington, 99202, United States

  • Southeast Lung Associates Research

    RECRUITING

    Rincon, Georgia, 31326, United States

  • Southwest Family Medicine

    RECRUITING

    Dallas, Texas, 75235, United States

  • Springhill Medical Center

    NOT_YET_RECRUITING

    Mobile, Alabama, 36608, United States

  • St. Lukes Sleep Medicine and Research Center

    RECRUITING

    Chesterfield, Missouri, 63017, United States

    Contact Email: •••••@•••••

  • Stanford Center for Sleep Sciences and Medicine

    RECRUITING

    Redwood City, California, 94063, United States

  • Stern Research Partners

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • TPMG Clinical Research

    NOT_YET_RECRUITING

    Williamsburg, Virginia, 23188, United States

  • The Cleveland Clinic Foundation

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Trial Site Solutions

    RECRUITING

    San Ramon, California, 94583, United States

  • Tricoastal Narcolepsy and Sleep Disorders Center

    RECRUITING

    Sugar Land, Texas, 77478, United States

    Contact Email: •••••@•••••

  • University of California San Francisco

    NOT_YET_RECRUITING

    San Francisco, California, 94107, United States

  • University of Kansas Hospital Main Campus

    NOT_YET_RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Pittsburgh

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Wisconsin-Madison

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53719, United States

  • West Coast Pulmonary & Sleep Disorders Center

    NOT_YET_RECRUITING

    Lancaster, California, 93534, United States

  • West Virginia University Hospital

    NOT_YET_RECRUITING

    Morgantown, West Virginia, 26506, United States

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Other studies related to the condition(s) this trial covers.