A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy
brief summary
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.
detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of Samelisant compared to placebo in the treatment of excessive daytime sleepiness in male or female participants ≥18 years of age with narcolepsy with and without cataplexy.
Participants will be randomized to receive either Samelisant or matching placebo tablets for duration of 12 weeks. Treatment allocation will remain blinded to both participants and investigators throughout the study, except in cases of medical necessity.
official title
A Phase 3, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Samelisant Compared to Placebo in Patients With Narcolepsy With or Without Cataplexy