NCT06103825

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)

A Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Treatment with Solriamfetol in Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea Syndrome (OSA) with a 12-week Treatment Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Ignis Therapeutics (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center, parallel-design.

Conditions

• Sleep Apnea, Obstructive
• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	Solriamfetol	solriamfetol : QD，PO，Day 1-Day 84；
DRUG	Placebo	Placebo :QD，PO，Day 1-Day 84

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-07-20
• Completion: 2024-08-19
• First posted: 2023-10-27
• Last updated: 2025-03-03

Locations

26 sites across 1 country: China