New hope for chronic sleepiness: phase 3 drug trial launches

NCT ID NCT07500090

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

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 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.

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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

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••
Contact

Email: •••••@•••••

Locations

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
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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