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Phase 3 Study of HBS-301 for Idiopathic Hypersomnia

This study is testing HBS-301 tablets to see how well they work and if they are safe for adults with idiopathic hypersomnia (IH). IH is a condition that causes extreme daytime sleepiness. You would be randomly assigned to receive either HBS-301 or a placebo (an inactive tablet that looks like the study drug). The main goal is to see if HBS-301 can reduce your sleepiness, measured by a scale called the Epworth Sleepiness Scale (ESS), over 8 weeks. To join, you must be at least 18 years old and have a confirmed diagnosis of IH based on specific sleep tests. The study plans to include about 248 participants. The current recruitment status is unclear.

Study design
This is a Phase 3, randomized, double-blind study, meaning neither you nor your doctor will know if you are receiving HBS-301 or a placebo. Approximately 248 participants will be enrolled.
What's involved
The study involves a screening period of up to 28 days, followed by an 8-week treatment period. There is also an optional open-label extension period that can last for 1 year.
Compensation
Not stated in the trial record.
Follow-up
After the treatment period, there will be a 30-day safety follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07500090

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Harmony Biosciences Management, Inc.
~248 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:HBS-301 tabletPlacebo

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)
Measured over Baseline to the end of the Double-blind Treatment Period (8 weeks)

Conditions

Idiopathic Hypersomnia

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Idiopathic Hypersomnia

Where it's being run

40 sites across 21 states
Texas6
Georgia4
California3
North Carolina3
Pennsylvania3
Colorado2
Florida2
Michigan2

Study leadership

  • David Seiden, MD · STUDY_DIRECTOR · Harmony Biosciences Management, Inc.

Who to contact

Katie Wilmsen
[email protected]
443-309-5556
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)Baseline to the end of the Double-blind Treatment Period (8 weeks)

    The ESS is an 8-item, 4-point rating scale.