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A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy (SUVN-G3031 Trial)

Phase 2
Waitlist Available
Research Sponsored by Suven Life Sciences Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you ever been diagnosed with Narcolepsy by a sleep doctor?
Have undergone a daytime nap test (MSLT) study showing an MSLT of ≤ 8 minutes.
Timeline
Screening 1 month
Treatment Varies
Follow Up 7 days

Summary

This trial is testing a new drug called Samelisant to help people with narcolepsy, a sleep disorder. The study includes participants with and without cataplexy. Researchers want to see if Samelisant can reduce symptoms like excessive daytime sleepiness and sudden muscle weakness.

Eligible Conditions
  • Narcolepsy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be between 18 and 65 years old to participate.
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Your body weight is within the range of 18 to 45 kg/m2 based on your height.

Timeline

Screening ~ 1 month
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 1 month for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Epworth Sleepiness Scale (ESS)
Secondary study objectives
Clinical Global Impression of Severity (CGI-S)
Maintenance of Wakefulness Test (MWT)
Other study objectives
Clinical Global Impression of Change (CGI-C)
Patient Global Impression of Change (PGI-C)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SUVN-G3031 4mgExperimental Treatment1 Intervention
Orally taken once daily for 14 days
Group II: SUVN-G3031 2mgExperimental Treatment1 Intervention
Orally taken once daily for 14 days
Group III: PlaceboPlacebo Group1 Intervention
Orally taken once daily for 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SUVN-G3031
2016
Completed Phase 2
~280

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Suven Life Sciences LimitedLead Sponsor
12 Previous Clinical Trials
1,316 Total Patients Enrolled
1 Trials studying Narcolepsy
~31 spots leftby Dec 2025
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