Phase 3 HBS-301 for idiopathic hypersomnia
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension
This trial will test whether the oral medicine HBS-301 helps adults with idiopathic hypersomnia reduce daytime sleepiness, sleep inertia, and fatigue.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Harmony Biosciences Management, Inc. Industry-sponsored |
| Locations | 12 sites (Santa Monica, California and 11 other locations) |
| Trial ID | NCT07500090 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 3 study enrolling about 248 adults with idiopathic hypersomnia to compare HBS-301 tablets with placebo over an 8-week double-blind period. Participants must have a prior ICSD-3 diagnosis confirmed by PSG/MSLT and stable concomitant medications when allowed. The study includes a screening/baseline period, an optional 1-year open-label extension for responders, and a 30-day safety follow-up. Key outcomes focus on changes in excessive daytime sleepiness, sleep inertia, fatigue, and safety measures.
Who should consider this trial
Good fit: Ideal candidates are adults (age ≥18) with a documented ICSD-3 diagnosis of idiopathic hypersomnia confirmed by PSG/MSLT, who have moderate to very severe symptoms and are on stable doses of any permitted chronic medications.
Not a fit: People without a confirmed IH diagnosis, those with untreated or noncompliant obstructive sleep apnea or recent changes in medications that affect wakefulness, children, or those taking prohibited as-needed stimulants are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, HBS-301 could reduce excessive daytime sleepiness, sleep inertia, and fatigue and improve daily functioning and quality of life for people with idiopathic hypersomnia.
How similar studies have performed: Related drugs acting on the histamine H3 pathway, including pitolisant, have shown benefit for excessive daytime sleepiness in narcolepsy and some data in hypersomnolence, so the mechanism has supporting evidence though Phase 3 data in IH remain needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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, an actigraphy report with sleep log on file that led to the diagnosis and was completed within the last 10 years. * Has moderate to very severe symptoms of IH. * If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants, 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. 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. * For participants being treated for obstructive sleep apnea (OSA) or other hypoventilatory conditions, must be compliant with their medical device or oral appliance as determined by the Investigator. Participants must maintain OSA treatment compliance throughout the study. 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 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).
Where this trial is running
Santa Monica, California and 11 other locations
- Santa Monica Clinical Trials — Santa Monica, California, United States (Recruiting)
- PharmDev Research Institute, LLC — Miami, Florida, United States (Recruiting)
- Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) — Winter Park, Florida, United States (Recruiting)
- NeuroTrials Research Inc. — Atlanta, Georgia, United States (Recruiting)
- Phillip Nowlin — Stockbridge, Georgia, United States (Recruiting)
- St. Luke's Hospital, Sleep Medicine and Research Center — Chesterfield, Missouri, United States (Recruiting)
- Clinical Research of Gastonia — Gastonia, North Carolina, United States (Recruiting)
- Stern Research Partners, LLC — Huntersville, North Carolina, United States (Recruiting)
- David Kudrow, MD — Morrisville, North Carolina, United States (Recruiting)
- Respiratory Specialists — Wyomissing, Pennsylvania, United States (Recruiting)
- K2 Medical Research — Nashville, Tennessee, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Katie Wilmsen
- Email: clinicaltrials@harmonybiosciences.com
- Phone: 443-309-5556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.