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Pitolisant shows promise for Long-Term control of idiopathic hypersomnia

NCT ID NCT05458128

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

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.

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.

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

119 people

The number who actually took part.

Started

Aug 2022

Finished

Oct 2025

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: 1. Is able to provide voluntary, informed consent. 2. Completed the Double-Blind Randomized Withdrawal Phase (EOT/Visit 5) from the HBS-101-CL-010 study. 3. A patient who is a female of child-bearing potential must have a negative urine pregnancy test at the Screening Visit. A patient who is a female of child-bearing potential must agree to remain abstinent or use an effective method of non-hormonal contraception to prevent pregnancy for the duration of the study and for 21 days after final dose of study drug. 4. Must have a negative result on urine drug screen at the Screening Visit, except for medications that are prescribed by a healthcare provider for medical conditions. 5. In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and administration of oral study drug. Exclusion Criteria: 1. Does not agree to discontinue any prohibited medication or substances listed in the protocol. 2. Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 21 days after final dose of study drug. 3. Participation in an interventional research study with an investigational medication or device, other than pitolisant, for the duration of the study. 4. Has a diagnosis of end-stage renal disease (ESRD; estimated glomerular filtration rate \[eGFR\] of \<15 mL/minute/1.73 m2) or severe hepatic impairment (Child-Pugh C). 5. Is receiving or is unable to discontinue a medication known to prolong the QT interval. 6. Has a significant risk of committing suicide or suicidality based on history; routine psychiatric examination; Investigator's judgment; or who has an answer of "yes" on any question other than questions 1 to 3 or "yes" on any question in the suicidal behavior section of the C-SSRS, Since Last Visit. 7. Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to an unstable or uncontrolled medical condition or one that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the patient, or compromise the integrity of the study.

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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.

Excessive daytime sleepiness Idiopathic hypersomnia

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

More trials for these conditions

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