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Samelisant for Narcolepsy

SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Suven Life Sciences Limited
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with narcolepsy (with or without cataplexy) who have a BMI between 18 and 45, experience significant daytime sleepiness, and can follow study procedures like keeping a sleep diary. People must be willing to comply fully with the study.

Inclusion Criteria

Body mass index ranging from 18 to 45 kg/m2 (both inclusive)
Able to show compliance with sleep diary entries at least 5 times/week in final 2 weeks of screening period
At screening and Baseline Visit, participants not on treatment for EDS must have ESS scores ≥12 (look-back period of 1 week)
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Exclusion Criteria

History of or current substance use disorder involving illicit drugs, alcohol, or marijuana within past 3 months per DSM-5-TR; alcohol/recreational drug use within 24 hours of study visits prohibited
Excessive caffeine use (>600 mg/day) at least 1 week prior to Baseline and during study
Nicotine dependence affecting sleep (e.g., awakening at night to smoke)
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What Are the Treatments Tested in This Trial?

Interventions

  • Samelisant

Trial Overview

The study compares Samelisant, a new medication, to a placebo in people with narcolepsy over 12 weeks. It looks at how well Samelisant reduces daytime sleepiness and cataplexy episodes, as well as its effects on alertness and quality of life.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Samelisant TabletsActive Control1 Intervention
Group II: Placebo TabletsPlacebo Group1 Intervention

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Who Is Running the Clinical Trial?

Suven Life Sciences Limited

Lead Sponsor

Trials
14
Recruited
1,700+

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