Status: Not yet recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
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.
Participants needed: 240
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Suven Life Sciences LimitedUpdated: Jun 16, 2026
Eligibility criteria
Body mass index ranging from 18 to 45 kg/m2 (both inclusive). [+6]
Median habitual wake-up time after 9 am as assessed by sleep diary, habitual sle... [+9]