RecruitingPhase 3NCT07500090
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
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
Sponsor
Harmony Biosciences Management, Inc.
Enrollment
248 participants
Start Date
Mar 16, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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).
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Interventions
DRUGHBS-301 tablet
HBS-301 tablet
DRUGPlacebo
Placebo tablet
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07500090
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