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

Completed · Phase 1

Conditions studied: Narcolepsy

In brief

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

Key facts

Study ID

NCT07051252

Run by

Harmony Biosciences Management, Inc.

People needed

46

Starts

2025-05-21

Expected to finish

2025-10-13

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.

You may not qualify if…

• 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.

Where it is running

• Harmony Site 9 — San Ramon, California, United States
• Harmony Site 14 — Brandon, Florida, United States
• Harmony Site 4 — Miami, Florida, United States
• Harmony Site 8 — Atlanta, Georgia, United States
• Harmony Site 13 — Newton, Massachusetts, United States
• Harmony Site 11 — Troy, Michigan, United States
• Harmony Site 10 — Denver, North Carolina, United States
• Harmony Site 2 — Huntersville, North Carolina, United States
• Harmony Site 6 — Canton, Ohio, United States
• Harmony Site 1 — Cincinnati, Ohio, United States
• Harmony Site 15 — Wyomissing, Pennsylvania, United States
• Harmony Site 5 — Columbia, South Carolina, United States
• Harmony Site 12 — North Charleston, South Carolina, United States
• Harmony Site 3 — Austin, Texas, United States
• Harmony Site 7 — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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