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

Join a study on delayed-release Pitolisant for treatment insights.

Recruiting
18 years and older
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Phase 1
**Study Overview:** This research is looking at a medicine called HBS-201, also known as Pitolisant Delayed-release. It’s being tested on adults with narcolepsy, a condition that makes people very sleepy during the day. The study wants to see if starting at a regular dose is safe for people. The dose will be between 17.8 mg and 35.6 mg, which the FDA has approved for a similar drug, WAKIX. The study has three parts: 1. A *Screening/Baseline* period up to 30 days, where doctors check if you're fit for the study. 2. A 2-week *Open-Label* period where everyone receives the treatment. 3. A 30-day *Safety Follow-up* to ensure no health issues arise. **Key Points:** - **Duration:** The entire study could last up to 9 weeks including follow-ups. - **Participation:** You're eligible if you have narcolepsy Type 1 or 2, but you cannot have other sleep disorders or be on certain medications. - **Risks:** You must not have unstable health conditions that could affect the study's results or your safety. This study is only for those not currently using or who have not used WAKIX recently.
Study details
    Narcolepsy

NCT07051252

Harmony Biosciences Management, Inc.

19 July 2025

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