A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Harmony Site 9
RECRUITING
San Ramon
Florida
Harmony Site 14
RECRUITING
Brandon
Harmony Site 4
RECRUITING
Miami
Georgia
Harmony Site 8
RECRUITING
Atlanta
Massachusetts
Harmony Site 13
RECRUITING
Newton
Michigan
Harmony Site 11
RECRUITING
Troy
North Carolina
Harmony Site 10
RECRUITING
Denver
Harmony Site 2
RECRUITING
Huntersville
Ohio
Harmony Site 6
RECRUITING
Canton
Harmony Site 1
RECRUITING
Cincinnati
Pennsylvania
Harmony Site 15
RECRUITING
Wyomissing
South Carolina
Harmony Site 5
RECRUITING
Columbia
Harmony Site 12
RECRUITING
North Charleston
Texas
Harmony Site 3
RECRUITING
Austin
West Virginia
Harmony Site 7
NOT_YET_RECRUITING
Morgantown
Contact Information
Primary
Katie Wilmsen
kwilmsen@harmonybiosciences.com
443-309-5556
Backup
Michelle Manuel
mmanuel@harmonybiosciences.com
847-903-4610
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2025-11
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Harmony Biosciences Management, Inc.