A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
Purpose
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.
Conditions
- EDS
- Cataplexy
- Fatigue
- Narcolepsy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- Has hypersomnia due to another medical disorder. - Has a history of pitolisant use within 5 half-lives prior to Screening. - Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening). - Has any history of bipolar disorder or psychosis - Has acute or chronic liver disease or a history of moderate or severe hepatic impairment. - Has a body surface area-corrected estimated glomerular filtration rate (eGFR) <60 mL/min. - Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Phoenix Medical Group, PC
Peoria, Arizona 85381
Peoria, Arizona 85381
Santa Monica Clinical Trials
Los Angeles, California 90025
Los Angeles, California 90025
Stanford Center for Sleep Sciences and Medicine
Redwood City, California 94063
Redwood City, California 94063
Trial Site Solutions
San Ramon, California 94583
San Ramon, California 94583
Alpine Clinical Research Center, Inc
Boulder, Colorado 80301
Boulder, Colorado 80301
Delta Waves LLC
Colorado Springs, Colorado 80918
Colorado Springs, Colorado 80918
PharmaDev Clinical Research Institute, LLC
Miami, Florida 33176
Miami, Florida 33176
Florida Pediatric Sleep Disorders Institute
Winter Park, Florida 32789
Winter Park, Florida 32789
Neurotrials Research Inc
Atlanta, Georgia 30328
Atlanta, Georgia 30328
Sleep Practitioners, LLC
Macon, Georgia 31210
Macon, Georgia 31210
Southeast Lung Associates Research
Rincon, Georgia 31326
Rincon, Georgia 31326
Clinical Research Institute Stockbridge
Stockbridge, Georgia 30281
Stockbridge, Georgia 30281
Revive Research Institute, Inc
Southfield, Michigan 48075
Southfield, Michigan 48075
Clinical Neurophysiology Services
Sterling Heights, Michigan 48314
Sterling Heights, Michigan 48314
St. Lukes Sleep Medicine and Research Center
Chesterfield, Missouri 63017
Chesterfield, Missouri 63017
Clinical Research of Gastonia
Gastonia, North Carolina 28054
Gastonia, North Carolina 28054
Stern Research Partners
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Intrepid Research, LLC
Cincinnati, Ohio 45245
Cincinnati, Ohio 45245
Abington Neurological Associates
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania 19610
Wyomissing, Pennsylvania 19610
Lowcountry Lung and Critical Care PA
Charleston, South Carolina 29406
Charleston, South Carolina 29406
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201
Columbia, South Carolina 29201
Southwest Family Medicine
Dallas, Texas 75235
Dallas, Texas 75235
Sleep Therapy & Research Center
San Antonio, Texas 78229
San Antonio, Texas 78229
Tricoastal Narcolepsy and Sleep Disorders Center
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Sleep and Performance Research Center
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- Status
- Recruiting
- Sponsor
- Harmony Biosciences Management, Inc.
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.