Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating HBS-301 for Narcolepsy Symptoms with Open-Label Extension

What This Trial Is About

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effectiveness and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in this population. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking during an 8-week double-blind treatment period. After this, participants may opt into a one-year open-label extension where all receive HBS-301. The study begins with a screening and baseline period lasting up to 28 days, followed by the treatment phases, and concludes with a 30-day safety follow-up. During the study, participants will undergo various assessments including the Epworth Sleepiness Scale to measure changes in daytime sleepiness, evaluations of cataplexy frequency, fatigue levels, sleepinesswakefulness tests, and quality of life questionnaires. Safety will be monitored throughout the entire study duration of approximately 16 months. Participants will have scheduled visits for assessments during each phase to track treatment effects and safety.

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