NCT04072380

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

A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	SUVN-G3031	SUVN-G3031 Tablets
DRUG	Placebo	Placebo Tablets

Timeline

• Start date: 2019-09-21
• Primary completion: 2023-06-07
• Completion: 2023-06-13
• First posted: 2019-08-28
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

41 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study