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
Stanford Center for Sleep Medicine
Redwood City, California 94063
United States
Santa Monica Clinical Trials
Santa Monica, California 90404
United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado 80301
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
Phillip Nowlin
Stockbridge, Georgia 30281
United States
Revive Research Institute
Southfield, Michigan 48975
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
Suburban Research Associates
West Chester, Pennsylvania 19380
United States
Respiratory Specialists
Wyomissing, Pennsylvania 19610
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
Southwest Family Medicine Associates
Dallas, Texas 75235
United States
HAS Research
San Antonio, Texas 78240
United States
West Virginia University
Morgantown, West Virginia 26506
United States