A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

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 EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Approximately 258 participants are planned for randomization into 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 Period (1 year), and 30 days of safety follow-up.

• Change in Weekly Rate of Cataplexy (WRC) in participants with an average WRC of ≥3 over 2 consecutive weeks at Screening [Срок оценки: End of the Double-Blind Treatment Period (8 weeks)]
• Change in sleepiness/wakefulness measured by the Maintenance of Wakefulness Test (MWT) [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS-Fatigue-SF-7a) [Срок оценки: Baseline to end of Double-Blind Treatment Period (8 weeks)]
• Change in severity of EDS as measured by the ESS [Срок оценки: Baseline through Week 1 and through Week 2 of Titration Period (1 week and 2 weeks)]
• Onset of efficacy of HBS-301 compared with placebo in treating cataplexy measured by WRC in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening [Срок оценки: Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)]
• Change in severity of EDS as measured by the Clinical Global Impression of Change (EDS) [Срок оценки: Baseline to end of Double-blind Treatment Period (8 weeks)]
• Change in severity of EDS as measured by the Patient Global Impression of Severity (EDS) [Срок оценки: Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Improvement in the severity of EDS as measured by the Patient Global Impression of Change (EDS) [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in severity of cataplexy as measured by the Clinical Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in severity of cataplexy as measured by the Patient Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Improvement in severity of cataplexy as measured by the Patient Global Impression of Change (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in severity of fatigue as measured by the Patient Global Impression of Severity (Fatigue) [Срок оценки: Baseline to the end of Double-blind Treatment Period (8 weeks)]