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
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
• Has EDS.
• If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Locations
United States
Alabama
Sleep Disorders Center of Alabama
NOT_YET_RECRUITING
Birmingham
Springhill Medical Center
NOT_YET_RECRUITING
Mobile
Arizona
Phoenix Medical Group, PC
RECRUITING
Peoria
California
West Coast Pulmonary & Sleep Disorders Center
NOT_YET_RECRUITING
Lancaster
Santa Monica Clinical Trials
RECRUITING
Los Angeles
Stanford Center for Sleep Sciences and Medicine
RECRUITING
Redwood City
University of California San Francisco
NOT_YET_RECRUITING
San Francisco
Trial Site Solutions
RECRUITING
San Ramon
Colorado
Alpine Clinical Research Center, Inc
RECRUITING
Boulder
Delta Waves LLC
RECRUITING
Colorado Springs
Florida
PharmaDev Clinical Research Institute, LLC
RECRUITING
Miami
Florida Pediatric Sleep Disorders Institute
RECRUITING
Winter Park
Georgia
Neurotrials Research Inc
RECRUITING
Atlanta
Sleep Practitioners, LLC
RECRUITING
Macon
Southeast Lung Associates Research
RECRUITING
Rincon
Clinical Research Institute Stockbridge
RECRUITING
Stockbridge
Illinois
NorthShore University HealthSystem
NOT_YET_RECRUITING
Glenview
OSF St Francis Medical Center
NOT_YET_RECRUITING
Peoria
Indiana
Fort Wayne Neurological Center
NOT_YET_RECRUITING
Fort Wayne
Kansas
University of Kansas Hospital Main Campus
NOT_YET_RECRUITING
Kansas City
Michigan
Henry Ford Medical Center
NOT_YET_RECRUITING
Novi
Revive Research Institute, Inc
RECRUITING
Southfield
Clinical Neurophysiology Services
RECRUITING
Sterling Heights
Missouri
St. Lukes Sleep Medicine and Research Center
RECRUITING
Chesterfield
North Carolina
Research Carolina Elite LLC
NOT_YET_RECRUITING
Denver
Clinical Research of Gastonia
RECRUITING
Gastonia
Stern Research Partners
RECRUITING
Huntersville
New Jersey
Patient First MD
NOT_YET_RECRUITING
Middletown
New York
Northwell Health Physician Partners
NOT_YET_RECRUITING
New Hyde Park
Ohio
Intrepid Research, LLC
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
NOT_YET_RECRUITING
Cleveland
Oklahoma
Neurology Care
NOT_YET_RECRUITING
Ardmore
Pennsylvania
Abington Neurological Associates
RECRUITING
Abington
Geisinger Medical Center
NOT_YET_RECRUITING
Danville
University of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Berks Schuylkill Respiratory Specialists
RECRUITING
Wyomissing
Rhode Island
Infinity Medical Research Inc
NOT_YET_RECRUITING
East Providence
South Carolina
Lowcountry Lung and Critical Care PA
RECRUITING
Charleston
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Bogan Sleep Consultants, LLC
RECRUITING
Columbia
Tennessee
K2 Medical Research - Nashville
NOT_YET_RECRUITING
Nashville
Texas
Aayus Research
RECRUITING
Austin
Southwest Family Medicine
RECRUITING
Dallas
Metroplex Pulmonary and Sleep Center
NOT_YET_RECRUITING
Mckinney
HasResearch
NOT_YET_RECRUITING
San Antonio
Sleep Therapy & Research Center
RECRUITING
San Antonio
Tricoastal Narcolepsy and Sleep Disorders Center
RECRUITING
Sugar Land
Virginia
TPMG Clinical Research
NOT_YET_RECRUITING
Williamsburg
Washington
Sleep and Performance Research Center
RECRUITING
Spokane
Wisconsin
University of Wisconsin-Madison
NOT_YET_RECRUITING
Madison
West Virginia
West Virginia University Hospital
NOT_YET_RECRUITING
Morgantown
Other Locations
Canada
AMNDX Inc
RECRUITING
Markham
Jodha Tishon Inc
RECRUITING
Toronto
Contact Information
Primary
Michelle Manuel
clinicaltrials@harmonybiosciences.com
847-903-4610
Backup
Katie Wilmsen
clinicaltrials@harmonybiosciences.com
443-309-5556
Time Frame
Start Date: 2026-06-04
Estimated Completion Date: 2027-11
Participants
Target number of participants: 258
Treatments
Experimental: Double-Blind Treatment Period HBS-301
HBS-301 tablets administered once daily in the morning upon wakening
Placebo_comparator: Double-blind Treatment Period Placebo
Matching placebo tablets administered once daily in the morning upon wakening
Experimental: Open-Label Extension Period HBS-301
HBS-301 tablets administered once daily in the morning upon wakening
Related Therapeutic Areas
Sponsors
Leads: Harmony Biosciences Management, Inc.