Approximately 248 participants are planned for randomization in the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension (OLE) Period (1 year), and 30 days of safety follow-up.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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).
