A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
Start Date
6/4/2026
Completion Date
11/1/2027
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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Detailed Description
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 treating EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy. Approximately 258 participants are planned for randomization into 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 Period (1 year), and 30 days of safety follow-up.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HBS-301
Placebo
Conditions
Locations
Phoenix Medical Group, PC
Peoria, Arizona 85381
United States
Santa Monica Clinical Trials
Los Angeles, California 90025
United States
Alpine Clinical Research Center, Inc
Boulder, Colorado 80301
United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida 33176
United States
Central Florida Pediatric Sleep Disorders Institute
Winter Park, Florida 32789
United States
Neurotrials Research Inc
Atlanta, Georgia 30328
United States
Sleep Practitioners, LLC
Macon, Georgia 31210
United States
Intrepid Research, LLC
Cincinnati, Ohio 45245
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
Southwest Family Medicine
Dallas, Texas 75235
United States
Sleep Therapy & Research Center
San Antonio, Texas 78229
United States
Sleep and Performance Research Center
Spokane, Washington 99202
United States