A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
Key facts
- Where
- Berlin, Munich, and Schwerin, GermanySee the 3 sites
- Phase
- Phase 3
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- LMU Klinikum Muenchen AöRMunich, GermanyNot yet recruiting
- Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbHSchwerin, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Harmony Biosciences Management, Inc.
- Trial code
- NCT07675135EU 2025-523821-17-00
- Record updated
- 27 August 2026
- Original description
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Inclusion: Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years; Has EDS; If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Exclusion: Has a history of pitolisant use within 5 half-lives prior to Screening; Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening); Has hypersomnia due to another medical disorder; Has any history of bipolar disorder or psychosis; Has acute or chronic liver disease or a history of moderate or severe hepatic impairment; Has a body surface area-corrected estimated glomerular filtration rate (eGFR) <60 mL/min; Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).