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)
- Conditions
- Sleep Apnea, ObstructiveExcessive Daytime Sleepiness
- Interventions
- Drug: Placebo
- Registration Number
- NCT06103825
- Lead Sponsor
- Ignis Therapeutics (Suzhou) Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strengths of solriamfetol (JZP-110) strengths: 37.5 mg，75 mg, 150 mg Solriamfetol subject will first enter a 2-week Titration Phase, during which the initial dose will be 37.5mg. The dose will be increased from 37.5mg QD to 75mg QD after 3 days, and then to 150mg QD at the first day of the second week if well-tolerated. subjects will then enter the 10-week Maintenance Phase on 150mg QD if well-tolerated. If a subject tolerability issues after titration up to 150mg at the second week, the dose can be reduced to 75mg QD following instructions of the investigators. This subject will then enter the 10-week Maintenance Phase on 75mg QD. If a subject experiences tolerability issues after titration up to 75mg at the first week, the dose can be reduced to 37.5mg QD following instructions of the investigators. The dose will be increased to 75mg QD again at the first day of the second week. Subject will then enter the 10-week Maintenance Phase on 75mg QD if well-tolerated. All subjects should be maintained on either 75mg QD or 150mg QD during the Maintenance Phase. matching Placebo Placebo -
- Primary Outcome Measures
Name Time Method To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 12 in the mean MWT sleep latency (minutes, (determined from the first four 40-minute trials of the MWT) From enrollment to the end of treatment at 12 weeks Change from baseline in mean MWT sleep latency (minutes, determined from the first four 40-minute trials of the MWT) to Week 12
To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 12 in ESS scores From enrollment to the end of treatment at 12 weeks Change from baseline in ESS total score to Week 12 Epworth Sleepiness Scale (ESS): ESS score ranges from 0 to 24 (inclusive), with higher score denoting greater degrees of sleepiness
- Secondary Outcome Measures
Name Time Method Key Secondary Study Objective: To compare treatment with solriamfetol versus placebo on the percentage of participants reported as improved (minimally, much, very much) in PGIc at Week 12 among patients with OSA From enrollment to the end of treatment at 12 weeks Percentage of participants with improved PGIc at Week 12
Other Secondary Study Objective 1:To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 2 and Week 5 in the mean MWT sleep latency From enrollment to the end of treatment at the 2- and 5-week Changes from baseline in MWT at the end of the Week 2 and Week 5 are defined as: mean sleep latency at the end of the Week 2 and Week 5 (determined from the first four 40-minute trials of the MWTs) minus the baseline measurement (minutes)
Other Secondary Study Objective 2: To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 2, 5 and 8 in ESS score From enrollment to the end of treatment at the 2- ,5- and 8-week Changes from baseline in ESS scores at the end of Week 2, 5 and 8 are defined as: ESS total scores at the end of Week 2, 5 and 8 minus baseline values Epworth Sleepiness Scale (ESS): ESS score ranges from 0 to 24 (inclusive), with higher score denoting greater degrees of sleepiness
Other Secondary Study Objective 3: To compare treatment with solriamfetol versus placebo on the percentage of participants reported as improved (minimally, much, very much) in PGIc at Week 2, 5 and 8 among patients with OSA From enrollment to the end of treatment at the 2- ,5- and 8-week The percentages of participants reported as improved (minimally, much, very much) in PGIc at Week 2, 5 and 8 are defined as the percentages calculated by dividing the number of participants reported as improved in PGIc by the total number of participants in the each treatment group at Week 2, 5 and 8
Other Secondary Study Objective 4: To compare treatment with solriamfetol versus placebo on the percentage of participants rated as improved (minimally, much, very much) in CGIc at Week 12 among patients with OSA From enrollment to the end of treatment at 12 weeks The percentage of participants rated as improved (minimally, much, very much) in CGIc at the end of Week 12 is defined as the percentage calculated by dividing the number of participants who have achieve improvement (minimally, much, very much) in CGIc by the total number of participants in each treatment group at Week 12
Other Secondary Study Objective 5: To compare treatment with solriamfetol versus placebo on the percentage of participants rated as improved (minimally, much, very much) in CGIc at Week 2, 5 and 8 among patients with OSA From enrollment to the end of treatment at the 2- ,5- and 8-week The percentage of participants rated as improved (minimally, much, very much) in CGIc at the end of Week 12 is defined as the percentage calculated by dividing the number of participants who have achieve improvement (minimally, much, very much) in CGIc by the total number of participants in each treatment group at Week 2, 5 and 8
Other Secondary Study Objective 6: To compare the efficacy of solriamfetol versus placebo throughout the day in sleep latency for each of the 5 MWT trials From enrollment to the end of treatment at 12 weeks Changes of the efficacy throughout the day in MWT: changes in sleep latency for each of the 5 MWTs (minutes)
Trial Locations
- Locations (26)
West China fourth Hospital Sichuan University
🇨🇳Sichuan, China
ShenZhen People's Hospital
🇨🇳Shenzhen, China
Shanghai Sixth People's Hospital
🇨🇳ShangHai, Shanghai, China
Beijing TianTan Hospital Capital Medical University
🇨🇳Beijing, China
China-Japan friendship Hospital
🇨🇳Beijing, China
Peking University Sixth Hospital
🇨🇳Beijing, China
XuanWu Hospital Capital Medical University
🇨🇳Beijing, China
The first hospital of Jilin University
🇨🇳Changchun, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
ChongQing University three gorges Hospital
🇨🇳Chongqing, China
The Hospital Group of the First Affiliated Hospital of CQMU
🇨🇳Chongqing, China
GanSU Provincial Hospital
🇨🇳Gansu, China
The first affiliated hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The first affiliated hospital of JiNan University
🇨🇳Guangzhou, China
Hangzhou seventh People's Hospital
🇨🇳Hangzhou, China
The first hospital of Hebei Medical University
🇨🇳Hebei, China
Huai'an First People's Hospital
🇨🇳Huai'an, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The Fitst Affiliated Hospital of NingBo University
🇨🇳Ningbo, China
ShanDong Provincial QianFoShan Hospital
🇨🇳Shandong, China
HuaShan Hospital FuDan University
🇨🇳Shanghai, China
First hospital of ShanXi Medical University
🇨🇳Shanxi, China
Second hospital of Shanxi Medical University
🇨🇳Shanxi, China
The Second Affiliated Hospital of Suzhou University
🇨🇳Suzhou, China
Yan'an University Xianyang Hospital
🇨🇳Xianyang, China
The First People's Hospital of YunNan Province
🇨🇳Yunnan, China