RecruitingIdiopathic Hypersomnia

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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).

Sponsor: Harmony Biosciences Management, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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).