Actively Recruiting
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Led by Harmony Biosciences Management, Inc. · Updated on 2026-03-30
248
Participants Needed
12
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 idiopathic hypersomnia (IH) symptoms, including excessive daytime sleepiness (EDS), sleep inertia, and fatigue in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH). The primary objective of this study is to evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms. Secondary objectives include evaluating the efficacy of HBS-301 compared with placebo in treating EDS, sleep inertia, and fatigue.
CONDITIONS
Official 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...
- Adults aged 18 years or older
- Current documented diagnosis of idiopathic hypersomnia using ICSD-3 or ICSD-3-TR criteria with confirmatory sleep studies completed within the last 10 years
- Moderate to very severe symptoms of idiopathic hypersomnia
- Stable dose of any permitted chronic medications or supplements, including allowed antidepressants, for at least 3 months before screening and willingness to maintain dose during double-blind treatment
- Compliance with medical device or oral appliance treatment for obstructive sleep apnea or other hypoventilatory conditions if applicable, maintained throughout the study
You will not qualify if you...
- Hypersomnia caused by another medical disorder
- Use of pitolisant within 5 half-lives before screening
- Primary diagnosis of uncontrolled psychiatric illness
- History of moderate or severe liver impairment
- Body surface area-corrected estimated glomerular filtration rate below 60 mL/min
- Known history of long QT syndrome or significant abnormal electrocardiogram findings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
7
Clinical Research of Gastonia
Gastonia, North Carolina, United States, 28054
Actively Recruiting
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
Actively Recruiting
Research Team
K
Katie Wilmsen
CONTACT
M
Michelle Manuel
CONTACT
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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