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A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of HBS-301 in Adults With Idiopathic Hypersomnia Followed by an Open-label Extension
Led by Harmony Biosciences Management, Inc. · Updated on 2026-03-30
248
Participants Needed
12
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HBS-301, a medication, in adults aged 18 years and older who have idiopathic hypersomnia (IH), a condition causing excessive daytime sleepiness (EDS), sleep inertia, and fatigue. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of HBS-301 in improving IH symptoms compared to a placebo. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking, at least one hour before meals. The study includes a Screening/Baseline Period lasting up to 28 days, followed by an 8-week Double-blind Treatment Period. After this, participants may join an optional Open-label Extension lasting one year. A 30-day safety follow-up period will occur after the treatment phases. During the study, participants will undergo evaluations of IH symptoms, including EDS, sleep inertia, and fatigue. Researchers will monitor safety throughout the 16-month study duration, including the extension phase. Outcome measures will include symptom severity, cognitive complaints, quality of life, and work productivity. Pharmacokinetic assessments of the drug and its metabolites will also be performed. Participants are expected to maintain stable doses of certain medications and comply with any sleep apnea treatment throughout the study.
CONDITIONS
Brief Title
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current documented diagnosis of idiopathic hypersomnia confirmed by International Classification of Sleep Disorders criteria with sleep test reports within the last 10 years
- Moderate to very severe symptoms of idiopathic hypersomnia
- Stable dose of permitted chronic medications or supplements for at least 3 months prior to screening
- Compliance with medical device or oral appliance treatment if being treated for obstructive sleep apnea or other hypoventilatory conditions
- Age 18 years or older
You will not qualify if you...
- Hypersomnia caused by another medical disorder
- Use of pitolisant within 5 half-lives prior to screening
- Primary psychiatric illness that is not well controlled
- History of moderate or severe liver impairment
- Estimated glomerular filtration rate under 60 mL/min
- Known history of long QT syndrome or serious electrocardiogram abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 8 weeks
Participants receive HBS-301 or placebo tablets once daily in the morning to assess the efficacy and safety in treating idiopathic hypersomnia symptoms.
Multiple visits over 8 weeks during treatment
Duration - 1 year
Participants who complete the double-blind period may continue receiving HBS-301 tablets once daily in an open-label extension to further assess long-term safety and efficacy.
Periodic visits during the 1-year extension
Duration - 30 days
Participants are monitored for safety for 30 days after completing the treatment or extension periods.
1 follow-up visit (in-person)
Trial Site Locations
Total: 12 locations
1
Santa Monica Clinical Trials
Santa Monica, California, United States, 90404
Actively Recruiting
2
PharmDev Research Institute, LLC
Miami, Florida, United States, 33176
Actively Recruiting
3
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)
Winter Park, Florida, United States, 32789
Actively Recruiting
4
NeuroTrials Research Inc.
Atlanta, Georgia, United States, 30328
Actively Recruiting
5
Phillip Nowlin
Stockbridge, Georgia, United States, 30281
Actively Recruiting
6
St. Luke's Hospital, Sleep Medicine and Research Center
Chesterfield, Missouri, United States, 63017
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7
Clinical Research of Gastonia
Gastonia, North Carolina, United States, 28054
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8
Stern Research Partners, LLC
Huntersville, North Carolina, United States, 28078
Actively Recruiting
9
David Kudrow, MD
Morrisville, North Carolina, United States, 27560
Actively Recruiting
10
Respiratory Specialists
Wyomissing, Pennsylvania, United States, 19610
Actively Recruiting
11
K2 Medical Research
Nashville, Tennessee, United States, 37204
Actively Recruiting
12
West Virginia University
Morgantown, West Virginia, United States, 26506
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Research Team
K
Katie Wilmsen
M
Michelle Manuel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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