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
Sleep Disorders Center of Alabama
Birmingham, Alabama 35213
United States
Springhill Medical Center
Mobile, Alabama 36608
United States
Phoenix Medical Group, PC
Peoria, Arizona 85381
United States
West Coast Pulmonary & Sleep Disorders Center
Lancaster, California 93534
United States
Santa Monica Clinical Trials
Los Angeles, California 90025
United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California 94063
United States
University of California San Francisco
San Francisco, California 94107
United States
Trial Site Solutions
San Ramon, California 94583
United States
Alpine Clinical Research Center, Inc
Boulder, Colorado 80301
United States
Delta Waves LLC
Colorado Springs, Colorado 80918
United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida 33176
United States
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
Southeast Lung Associates Research
Rincon, Georgia 31326
United States
Clinical Research Institute Stockbridge
Stockbridge, Georgia 30281
United States
NorthShore University HealthSystem
Glenview, Illinois 60026
United States
OSF St Francis Medical Center
Peoria, Illinois 61606
United States
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
United States
University of Kansas Hospital Main Campus
Kansas City, Kansas 66160
United States
Henry Ford Medical Center
Novi, Michigan 48377
United States
Revive Research Institute, Inc
Southfield, Michigan 48075
United States
Clinical Neurophysiology Services
Sterling Heights, Michigan 48314
United States
St. Lukes Sleep Medicine and Research Center
Chesterfield, Missouri 63017
United States
Patient First MD
Middletown, New Jersey 07748
United States
Northwell Health Physician Partners
New Hyde Park, New York 11042
United States
Research Carolina Elite LLC
Denver, North Carolina 28037
United States
Clinical Research of Gastonia
Gastonia, North Carolina 28054
United States
Stern Research Partners
Huntersville, North Carolina 28078
United States
Intrepid Research, LLC
Cincinnati, Ohio 45245
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Neurology Care
Ardmore, Oklahoma 73401
United States
Abington Neurological Associates
Abington, Pennsylvania 19001
United States
Geisinger Medical Center
Danville, Pennsylvania 17821
United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
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
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201
United States
K2 Medical Research - Nashville
Nashville, Tennessee 37204
United States
Aayus Research
Austin, Texas 78731
United States
Southwest Family Medicine
Dallas, Texas 75235
United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
United States
Sleep Therapy & Research Center
San Antonio, Texas 78229
United States
HasResearch
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
Sleep and Performance Research Center
Spokane, Washington 99202
United States
West Virginia University Hospital
Morgantown, West Virginia 26506
United States
University of Wisconsin-Madison
Madison, Wisconsin 53719
United States
AMNDX Inc
Markham, Ontario M5S 3A3
Canada
Jodha Tishon Inc
Toronto, Ontario M5S 3A3
Canada