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

NCT04072380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-01-13

Study results available
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Summary

This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.

Conditions

Interventions

DRUG

SUVN-G3031

SUVN-G3031 Tablets

DRUG

Placebo

Placebo Tablets

Sponsors & Collaborators

  • Suven Life Sciences Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-21
Primary Completion
2023-06-07
Completion
2023-06-13
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072380 on ClinicalTrials.gov