Phase 3 HBS-301 for idiopathic hypersomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 study enrolling about 248 adults with idiopathic hypersomnia to compare HBS-301 tablets with placebo over an 8-week double-blind period. Participants must have a prior ICSD-3 diagnosis confirmed by PSG/MSLT and stable concomitant medications when allowed. The study includes a screening/baseline period, an optional 1-year open-label extension for responders, and a 30-day safety follow-up. Key outcomes focus on changes in excessive daytime sleepiness, sleep inertia, fatigue, and safety measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• Sleep Disorders Center of Alabama
  Birmingham, Alabama, United States Recruiting
• Phoenix Medical Group LLC
  Peoria, Arizona, United States Recruiting
• Stanford Center for Sleep Medicine
  Redwood City, California, United States Recruiting
• Trial Site Solutions
  San Ramon, California, United States Recruiting
• Santa Monica Clinical Trials
  Santa Monica, California, United States Recruiting
• Alpine Clinical Research Center, Inc.
  Boulder, Colorado, United States Recruiting

Study contacts

• Study coordinator: Katie Wilmsen
• Email: clinicaltrials@harmonybiosciences.com
• Phone: 443-309-5556

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Long-term ORX750 treatment for people with narcolepsy or idiopathic hypersomnia

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• Diet changes to reduce sleepiness in narcolepsy and idiopathic hypersomnia

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• Evaluating TAK-360 for daytime sleepiness in adults with Idiopathic Hypersomnia

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• Long-term treatment with ALKS 2680 for narcolepsy and idiopathic hypersomnia

  This study is testing how well a new medication called ALKS 2680 works for people with narcolepsy or idiopathic hypersomnia over a long period of time.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.