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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Sponsor: Harmony Biosciences Management, Inc.
Summary
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2026-03-16
Completion Date
2028-10
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
HBS-301 tablet
HBS-301 tablet
Placebo
Placebo tablet
Locations (40)
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Phoenix Medical Group LLC
Peoria, Arizona, United States
Stanford Center for Sleep Medicine
Redwood City, California, United States
Trial Site Solutions
San Ramon, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Delta Waves LLC
Colorado Springs, Colorado, United States
PharmDev Research Institute, LLC
Miami, Florida, United States
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)
Winter Park, Florida, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
Southeast Lung Associates Research
Rincon, Georgia, United States
Clinical Research Institute Stockbridge
Stockbridge, Georgia, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Revive Research Institute
Southfield, Michigan, United States
Clinical Neuropsychology Services
Sterling Heights, Michigan, United States
St. Luke's Hospital, Sleep Medicine and Research Center
Chesterfield, Missouri, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Stern Research Partners, LLC
Huntersville, North Carolina, United States
David Kudrow, MD
Morrisville, North Carolina, United States
Neuroscience Research Center, LLC
Canton, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
Neurology Care
Ardmore, Oklahoma, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Suburban Research Associates
West Chester, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania, United States
Infinity Medical Research Inc.
East Providence, Rhode Island, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
K2 Medical Research
Nashville, Tennessee, United States
Aayus Research
Austin, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
HAS Research
San Antonio, Texas, United States
Tricoastal Narcolepsy and Sleep Disorders Center
Sugar Land, Texas, United States
TPMG Clinical Research
Williamsburg, Virginia, United States
Washington State University Sleep and Performance Center
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University of Washington
Madison, Wisconsin, United States