A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Start Date
3/16/2026
Completion Date
10/1/2028
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).
Detailed Description
Approximately 248 participants are planned for randomization in the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension (OLE) Period (1 year), and 30 days of safety follow-up.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HBS-301 tablet
Placebo
Conditions
Locations
Sleep Disorders Center of Alabama
Birmingham, Alabama 35213
United States
Phoenix Medical Group LLC
Peoria, Arizona 85381
United States
Stanford Center for Sleep Medicine
Redwood City, California 94063
United States
Trial Site Solutions
San Ramon, California 04583
United States
Santa Monica Clinical Trials
Santa Monica, California 90404
United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado 80301
United States
Delta Waves LLC
Colorado Springs, Colorado 80918
United States
PharmDev Research Institute, LLC
Miami, Florida 33176
United States
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)
Winter Park, Florida 32789
United States
NeuroTrials Research Inc.
Atlanta, Georgia 30328
United States
Sleep Practitioners, LLC
Macon, Georgia 31210
United States
Southeast Lung Associates Research
Rincon, Georgia 31326
United States
Clinical Research Institute Stockbridge
Stockbridge, Georgia 30281
United States
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
United States
Revive Research Institute
Southfield, Michigan 48975
United States
Clinical Neuropsychology Services
Sterling Heights, Michigan 48314
United States
St. Luke's Hospital, Sleep Medicine and Research Center
Chesterfield, Missouri 63017
United States
Clinical Research of Gastonia
Gastonia, North Carolina 28054
United States
Stern Research Partners, LLC
Huntersville, North Carolina 28078
United States
David Kudrow, MD
Morrisville, North Carolina 27560
United States
Neuroscience Research Center, LLC
Canton, Ohio 44718
United States
Intrepid Research
Cincinnati, Ohio 45245
United States
Neurology Care
Ardmore, Oklahoma 73401
United States
Abington Neurological Associates
Abington, Pennsylvania 19001
United States
Suburban Research Associates
West Chester, Pennsylvania 19380
United States
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania 19610
United States
Infinity Medical Research Inc.
East Providence, Rhode Island 02914
United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina 29406
United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201
United States
K2 Medical Research
Nashville, Tennessee 37204
United States
Aayus Research
Austin, Texas 78731
United States
Southwest Family Medicine Associates
Dallas, Texas 75235
United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
United States
Sleep Therapy and Research Center
San Antonio, Texas 30328
United States
HAS Research
San Antonio, Texas 78240
United States
Tricoastal Narcolepsy and Sleep Disorders Center
Sugar Land, Texas 77478
United States
TPMG Clinical Research
Williamsburg, Virginia 23188
United States
Washington State University Sleep and Performance Center
Spokane, Washington 99210
United States
West Virginia University
Morgantown, West Virginia 26506
United States
University of Washington
Madison, Wisconsin 53792
United States
AMNDX Inc
Markham, Ontario M5S 3A3
Canada
Jodha Tishon Inc
Toronto, Ontario M5S 3A3
Canada