A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarmony Biosciences Management, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Has hypersomnia due to another medical disorder.
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 any history of bipolar disorder or psychosis
Trial design
Treatments tested in this trial
- HBS-301
- Placebo
Treatment groups
258 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov