New hope for chronic sleepiness: Long-Term drug safety trial shows promise

NCT ID NCT05458128

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

First seen Jan 06, 2026 · Last updated Apr 30, 2026 · Updated 19 times

Summary

This study looked at the long-term safety and effectiveness of the drug pitolisant for adults with idiopathic hypersomnia, a condition causing excessive daytime sleepiness. Participants had already completed a previous pitolisant study. The goal was to see if the drug remains safe and helps reduce sleepiness over time. Results showed that pitolisant can be used long-term to manage symptoms, but it is not a cure.

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Contacts and locations

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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

Conditions

Explore the condition pages connected to this study.

EXCESSIVE DAYTIME SLEEPINESS EXCESSIVE DAYTIME SLEEPINESS IDIOPATHIC HYPERSOMNIA