Narcolepsy
Conditions
Keywords
Narcolepsy, Pitolisant hydrochloride, Pitolisant delayed-release
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.
Interventions
DRUGHBS-201
On Days 1-7, participants will take HBS-201 17.8 mg per day (one 17.8 mg tablet) and on Days 8-14, participants will take HBS-201 35.6 mg per day (two 17.8 mg tablets).
Sponsors
Harmony Biosciences Management, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed