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
Peoria, Arizona 85381
Los Angeles, California 90025
Boulder, Colorado 80301
Miami, Florida 33176
Winter Park, Florida 32789
Atlanta, Georgia 30328
Dennis Lacey
404-851-9934
Macon, Georgia 31210
Cincinnati, Ohio 45245
Wyomissing, Pennsylvania 19610
Charleston, South Carolina 29406
Columbia, South Carolina 29201
Dallas, Texas 75235
San Antonio, Texas 78229
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.