What is HBS-301 studying for idiopathic hypersomnia?

HBS-301 is being studied to see if it helps reduce symptoms of idiopathic hypersomnia, such as excessive daytime sleepiness, sleep inertia, and fatigue. The study compares HBS-301 to a placebo to evaluate its effects in adults with this condition. Harmony Biosciences Management, Inc. is sponsoring this research.

Who may be eligible for this idiopathic hypersomnia clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of idiopathic hypersomnia may be eligible. Participants must have moderate to very severe symptoms and be stable on certain medications. Those with other causes of hypersomnia or some heart and liver conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this idiopathic hypersomnia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07500090

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

Research Sites

52 weeks

Total Duration

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 ScreeningBaseline 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

Age: 18Years +

All Genders

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

Research Team

Katie Wilmsen

Michelle Manuel

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