CompletedPhase 1

A Study of HBS-201 (Pitolisant Delayed-release)

United States46 participantsStarted 2025-05-21

Plain-language summary

The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Has hypersomnolence due to another medical disorder.
✕. Is currently taking or has taken WAKIX (pitolisant).
✕. Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening.
✕. Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.

Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug

Timeframe: From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days

Frequency, severity, and seriousness of TEAEs

Timeframe: From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days

NCT IDNCT07051252

SponsorHarmony Biosciences Management, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-13