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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
258
Start Date
2026-06-04
Completion Date
2027-11
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
HBS-301
HBS-301 tablet
Placebo
Placebo tablet
Locations (53)
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Springhill Medical Center
Mobile, Alabama, United States
Phoenix Medical Group, PC
Peoria, Arizona, United States
West Coast Pulmonary & Sleep Disorders Center
Lancaster, California, United States
Santa Monica Clinical Trials
Los Angeles, California, United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, United States
University of California San Francisco
San Francisco, California, United States
Trial Site Solutions
San Ramon, California, United States
Alpine Clinical Research Center, Inc
Boulder, Colorado, United States
Delta Waves LLC
Colorado Springs, Colorado, United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States
Florida Pediatric Sleep Disorders Institute
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
NorthShore University HealthSystem
Glenview, Illinois, United States
OSF St Francis Medical Center
Peoria, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
University of Kansas Hospital Main Campus
Kansas City, Kansas, United States
Henry Ford Medical Center
Novi, Michigan, United States
Revive Research Institute, Inc
Southfield, Michigan, United States
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States
St. Lukes Sleep Medicine and Research Center
Chesterfield, Missouri, United States
Patient First MD
Middletown, New Jersey, United States
Northwell Health Physician Partners
New Hyde Park, New York, United States
Research Carolina Elite LLC
Denver, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Stern Research Partners
Huntersville, North Carolina, United States
Intrepid Research, LLC
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Neurology Care
Ardmore, Oklahoma, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, 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
Medical University of South Carolina
Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
K2 Medical Research - Nashville
Nashville, Tennessee, United States
Aayus Research
Austin, Texas, United States
Southwest Family Medicine
Dallas, Texas, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
HasResearch
San Antonio, Texas, United States
Tricoastal Narcolepsy and Sleep Disorders Center
Sugar Land, Texas, United States
TPMG Clinical Research
Williamsburg, Virginia, United States
Sleep and Performance Research Center
Spokane, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
AMNDX Inc
Markham, Ontario, Canada
Jodha Tishon Inc
Toronto, Ontario, Canada