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)

PHASE3CompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

July 20, 2024

Study Completion Date

August 19, 2024

Conditions
Sleep Apnea, ObstructiveExcessive Daytime Sleepiness
Interventions
DRUG

Solriamfetol

solriamfetol : QD,PO,Day 1-Day 84;

DRUG

Placebo

Placebo :QD,PO,Day 1-Day 84

Trial Locations (26)

Unknown

Shanghai Sixth People's Hospital, Shanghai

Beijing TianTan Hospital Capital Medical University, Beijing

China-Japan friendship Hospital, Beijing

Peking University Sixth Hospital, Beijing

XuanWu Hospital Capital Medical University, Beijing

The first hospital of Jilin University, Changchun

Xiangya Hospital Central South University, Changsha

ChongQing University three gorges Hospital, Chongqing

The Hospital Group of the First Affiliated Hospital of CQMU, Chongqing

GanSU Provincial Hospital, Gansu

The first affiliated hospital of Guangzhou Medical University, Guangzhou

The first affiliated hospital of JiNan University, Guangzhou

Hangzhou seventh People's Hospital, Hangzhou

The first hospital of Hebei Medical University, Hebei

Huai'an First People's Hospital, Huai'an

The Second Affiliated Hospital of Nanchang University, Nanchang

The Fitst Affiliated Hospital of NingBo University, Ningbo

ShanDong Provincial QianFoShan Hospital, Shandong

HuaShan Hospital FuDan University, Shanghai

First hospital of ShanXi Medical University, Shanxi

Second hospital of Shanxi Medical University, Shanxi

ShenZhen People's Hospital, Shenzhen

West China fourth Hospital Sichuan University, Sichuan

The Second Affiliated Hospital of Suzhou University, Suzhou

Yan'an University Xianyang Hospital, Xianyang

The First People's Hospital of YunNan Province, Yunnan

All Listed Sponsors
lead

Ignis Therapeutics (Suzhou) Limited

INDUSTRY