Evaluating Samelisant Tablets Compared to Placebo for Treating Excessive Daytime Sleepiness in Adults With Narcolepsy With or Without Cataplexy

What This Trial Is About

Researchers are evaluating the effects of Samelisant in adults aged 18 years and older who have narcolepsy, with or without cataplexy. This Phase 3 clinical trial aims to assess how Samelisant impacts excessive daytime sleepiness, the frequency of sudden muscle weakness episodes, attention, alertness, overall quality of life, and daily functioning. The study also examines the safety of Samelisant in this population. Participants will be randomly assigned to receive either Samelisant tablets or matching placebo tablets once daily for 12 weeks. The study is conducted in a double-blind manner, meaning neither participants nor investigators know which treatment is given, except in medical emergencies. The treatment period lasts for 12 weeks, during which participants take their assigned tablets daily. During the trial, participants will undergo various assessments including the Epworth Sleepiness Scale to measure daytime sleepiness, the Maintenance of Wakefulness Test, and clinical evaluations of cataplexy episodes and narcolepsy severity. Researchers will monitor safety and treatment adherence, and participants will be asked to complete sleep diaries regularly. The total participation duration covers screening and 12 weeks of treatment with follow-up assessments.

A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)