Pitolisant shows promise for Long-Term control of idiopathic hypersomnia

NCT ID NCT05458128

Completed Disease control Sponsor: Harmony Biosciences Management, Inc. Source: ClinicalTrials.gov ↗

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.

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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

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