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)

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.

Timeline

Start

2023-08-01

Primary completion

2024-07-20

Completion

2024-08-19

Publications

• Cheng H, Deng L, Meng Z, Zhang W, Chen T, Chen R, Tang S, Lv Y, Su X, Liu Z, Zhang X, Wang X, Mao H, Zhang N, Yu H, Pan J, Xie Y, Tang J, Yin S, Wang Z, Tong M, Zhan S, Wang C, Wang B, Zhang W, Mi W, Lu L. Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial. CNS Drugs. 2026 Jan;40(1):83-98. doi: 10.1007/s40263-025-01232-1. Epub 2025 Oct 23.

Drugs

Indications