A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
Condition
- Idiopathic Hypersomnia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years. - Has EDS. - Has moderate to very severe symptoms of IH. - 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 use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis 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. - Has a history of moderate or severe hepatic impairment. - Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min. - Has a known history of long QT syndrome or any significant history of a 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
Sleep Disorders Center of Alabama
Birmingham, Alabama 35213
Birmingham, Alabama 35213
Phoenix Medical Group LLC
Peoria, Arizona 85381
Peoria, Arizona 85381
Stanford Center for Sleep Medicine
Redwood City, California 94063
Redwood City, California 94063
Trial Site Solutions
San Ramon, California 04583
San Ramon, California 04583
Santa Monica Clinical Trials
Santa Monica, California 90404
Santa Monica, California 90404
Alpine Clinical Research Center, Inc.
Boulder, Colorado 80301
Boulder, Colorado 80301
Delta Waves LLC
Colorado Springs, Colorado 80918
Colorado Springs, Colorado 80918
PharmDev Research Institute, LLC
Miami, Florida 33176
Miami, Florida 33176
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)
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
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
Fort Wayne, Indiana 46804
Revive Research Institute
Southfield, Michigan 48975
Southfield, Michigan 48975
Clinical Neuropsychology Services
Sterling Heights, Michigan 48314
Sterling Heights, Michigan 48314
St. Luke's Hospital, 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, LLC
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
David Kudrow, MD
Morrisville, North Carolina 27560
Morrisville, North Carolina 27560
Neuroscience Research Center, LLC
Canton, Ohio 44718
Canton, Ohio 44718
Intrepid Research
Cincinnati, Ohio 45245
Cincinnati, Ohio 45245
Abington Neurological Associates
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
Suburban Research Associates
West Chester, Pennsylvania 19380
West Chester, Pennsylvania 19380
Berks Schuylkill Respiratory Specialists
Wyomissing, Pennsylvania 19610
Wyomissing, Pennsylvania 19610
Infinity Medical Research Inc.
East Providence, Rhode Island 02914
East Providence, Rhode Island 02914
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
K2 Medical Research
Nashville, Tennessee 37204
Nashville, Tennessee 37204
Southwest Family Medicine Associates
Dallas, Texas 75235
Dallas, Texas 75235
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
McKinney, Texas 75069
Sleep Therapy and Research Center
San Antonio, Texas 30328
San Antonio, Texas 30328
HAS Research
San Antonio, Texas 78240
San Antonio, Texas 78240
Tricoastal Narcolepsy and Sleep Disorders Center
Sugar Land, Texas 77478
Sugar Land, Texas 77478
TPMG Clinical Research
Williamsburg, Virginia 23188
Williamsburg, Virginia 23188
Washington State University Sleep and Performance Center
Spokane, Washington 99210
Spokane, Washington 99210
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Contact:
Lauren Chase
304-598-4000
Lauren Chase
304-598-4000
University of Washington
Madison, Wisconsin 53792
Madison, Wisconsin 53792
More Details
- Status
- Recruiting
- Sponsor
- Harmony Biosciences Management, Inc.
Detailed Description
Approximately 248 participants are planned for randomization in 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 (OLE) Period (1 year), and 30 days of safety follow-up.