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NOT YET RECRUITING
NCT07540364
PHASE3

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

Sponsor: Suven Life Sciences Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-06-19

Completion Date

2027-12-19

Last Updated

2026-06-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Samelisant

Tablet dosage form, once a day

DRUG

Placebo

Matching placebo tablets, once a day