A Study of HBS-201 (Pitolisant Delayed-release)
- Conditions
- Narcolepsy
- Interventions
- Drug: HBS-201
- Registration Number
- NCT07051252
- Lead Sponsor
- Harmony Biosciences Management, Inc.
- Brief 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.
- Detailed Description
This is a Phase 1b, open-label, multicenter study to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy. Therapeutic dose range is defined as 17.8 milligram (mg) to 35.6 mg based on the FDA-approved prescribing information for WAKIX.
The study will consist of an up to 30-day Screening/Baseline Period, a 2-week Open-Label Period, and a 30-day Safety Follow-up Period.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HBS-201 HBS-201 Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.
- Primary Outcome Measures
Name Time Method Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.
Frequency, severity, and seriousness of TEAEs From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
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
Scroll for more (5 remaining)Harmony Site 9🇺🇸San Ramon, California, United States