A Phase 1 interventional study of HBS-201 in Narcolepsy, sponsored by Harmony Biosciences Management, Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Harmony Biosciences Management, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
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.
149 studies on the registry are indexed under Narcolepsy; 33 are open to participants now.
This study's enrollment of 46 is below the median of 71 across 110 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →Harmony Biosciences Management, Inc. is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.
Drug: HBS-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).
Also known as: pitolisant delayed-release (DR), pitolisant hydrochloride
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.
Time frame: 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.
Time frame: From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Harmony Biosciences Management, Inc.