A Study of HBS-201 (Pitolisant Delayed-release)
A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy
1 other identifier
interventional
46
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2025
Shorter than P25 for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2025
CompletedFirst Submitted
Initial submission to the registry
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2025
CompletedDecember 12, 2025
December 1, 2025
5 months
June 30, 2025
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug
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.
From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days
Frequency, severity, and seriousness of TEAEs
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.
From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days
Study Arms (1)
HBS-201
EXPERIMENTALParticipants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.
Interventions
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).
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Harmony Site 9
San Ramon, California, 94583, United States
Harmony Site 14
Brandon, Florida, 33511, United States
Harmony Site 4
Miami, Florida, 33176, United States
Harmony Site 8
Atlanta, Georgia, 30328, United States
Harmony Site 13
Newton, Massachusetts, 02459, United States
Harmony Site 11
Troy, Michigan, 48085, United States
Harmony Site 10
Denver, North Carolina, 28037, United States
Harmony Site 2
Huntersville, North Carolina, 28078, United States
Harmony Site 6
Canton, Ohio, 44718, United States
Harmony Site 1
Cincinnati, Ohio, 45245, United States
Harmony Site 15
Wyomissing, Pennsylvania, 19610, United States
Harmony Site 5
Columbia, South Carolina, 29201, United States
Harmony Site 12
North Charleston, South Carolina, 29406, United States
Harmony Site 3
Austin, Texas, 78731, United States
Harmony Site 7
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2025
First Posted
July 4, 2025
Study Start
May 21, 2025
Primary Completion
October 13, 2025
Study Completion
October 13, 2025
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share