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

Launched by HARMONY BIOSCIENCES MANAGEMENT, INC. · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called HBS-201 (also known as pitolisant) to see how well adults with narcolepsy can tolerate starting treatment at a regular dose. Narcolepsy is a condition that causes excessive daytime sleepiness and sudden sleep attacks. This early-phase study is focused on understanding if the medicine is safe and comfortable for people to take when they begin treatment.

Adults aged 18 to 74 who have been officially diagnosed with narcolepsy type 1 or type 2 may be eligible to join. People who have sleepiness caused by other medical issues, who have taken pitolisant before, or who recently participated in other drug studies won’t qualify. Participants can expect to take the medicine and be monitored by the study team to see how their body reacts. The study is currently looking for volunteers, and those interested should discuss the details and any questions with the research staff to see if this trial is a good fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.
• Exclusion Criteria:
• • 1. Has hypersomnolence due to another medical disorder.
• • 2. Is currently taking or has taken WAKIX (pitolisant).
• • 3. 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.
• • 4. 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.