HBS-301 for Narcolepsy: daily wakefulness and sleepiness improvement in adults

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 large, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of HBS-301 in adults with narcolepsy. Approximately 258 participants will be randomized to receive either HBS-301 or placebo for 8 weeks, with an optional 1-year open-label extension and 30 days of follow-up. The trial includes a screening baseline period, a double-blind treatment period, and strict eligibility criteria to confirm NT1 or NT2 diagnosis and stable concomitant medications. Primary outcomes focus on excessive daytime sleepiness and related symptoms, with safety monitoring throughout. Lead sponsor is Harmony Biosciences Management, Inc., with sites in Alabama and Arizona.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
* Has EDS.
* 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 (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) 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 (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
* Has any history of bipolar disorder or psychosis
* Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
* Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
* Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).

Where it's running

• Phoenix Medical Group, PC
  Peoria, Arizona, United States Recruiting
• Santa Monica Clinical Trials
  Los Angeles, California, United States Recruiting
• Stanford Center for Sleep Sciences and Medicine
  Redwood City, California, United States Recruiting
• Trial Site Solutions
  San Ramon, California, United States Recruiting
• Alpine Clinical Research Center, Inc
  Boulder, Colorado, United States Recruiting
• Delta Waves LLC
  Colorado Springs, Colorado, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Michelle Manuel
• Email: clinicaltrials@harmonybiosciences.com
• Phone: 847-903-4610

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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.