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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Recruitment opened
    • Start date: Jun 19, 2026 to Sep 2026
    • Study sites: 0 to 1
    v3
  2. Study title expanded, about 1 wordv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07540364
Lead Sponsor Suven Life Sciences Limited
Conditions
(from sponsor)		 Narcolepsy
Related terms Cataplexy, Disorders of Excessive Somnolence, Narcolepsy
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov