A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension
Harmony Biosciences Management, Inc.
Summary
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 idiopathic hypersomnia (IH) symptoms, including excessive daytime sleepiness (EDS), sleep inertia, and fatigue in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH). The primary objective of this study is to evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms. Secondary objectives include evaluating the efficacy of HBS-301 compared with placebo in treating EDS, sleep inertia, and fatigue.
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 IH symptoms, including EDS, sleep inertia, and fatigue in adult participants (ages ≥18 years) with IH. Approximately 248 participants are planned for randomization in the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension (OLE) Period (1 year), and 30 days of safety follow-up.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT); and if applicable, an actigraphy report with sleep log on file that led to the diagnosis and was completed within the last 10 years. * Has moderate to very severe symptoms of IH. * If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants, must be on a stable dose for at least 3 months pr…
Interventions
- DrugHBS-301 tablet
HBS-301 tablet
- DrugPlacebo
Placebo tablet
Locations (12)
- Santa Monica Clinical TrialsSanta Monica, California
- PharmDev Research Institute, LLCMiami, Florida
- Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)Winter Park, Florida
- NeuroTrials Research Inc.Atlanta, Georgia
- Phillip NowlinStockbridge, Georgia
- St. Luke's Hospital, Sleep Medicine and Research CenterChesterfield, Missouri