Clinical Trial

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

Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-13.
Trial Details
NCT Number NCT07540364
Lead Sponsor Suven Life Sciences Limited
Conditions Narcolepsy
Enrollment 240 participants
Start Date 2026-06-19
Primary Completion 2027-11-19 (estimated)
Study Completion 2027-12-19 (estimated)
Updated on ClinicalTrials.gov 2026-06-16