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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
solriamfetol : QD,PO,Day 1-Day 84;
Placebo :QD,PO,Day 1-Day 84
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 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
...and 16 more locations
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)
Change from baseline in mean MWT sleep latency (minutes, determined from the first four 40-minute trials of the MWT) to Week 12
Time frame: From enrollment to the end of treatment at 12 weeks
To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 12 in ESS scores
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
Time frame: From enrollment to the end of treatment at 12 weeks
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
Percentage of participants with improved PGIc at Week 12
Time frame: From enrollment to the end of treatment at 12 weeks
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
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)
Time frame: From enrollment to the end of treatment at the 2- and 5-week
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
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
Time frame: From enrollment to the end of treatment at the 2- ,5- and 8-week
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
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
Time frame: From enrollment to the end of treatment at the 2- ,5- and 8-week
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
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
Time frame: From enrollment to the end of treatment at 12 weeks
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
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
Time frame: From enrollment to the end of treatment at the 2- ,5- and 8-week
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
Changes of the efficacy throughout the day in MWT: changes in sleep latency for each of the 5 MWTs (minutes)
Time frame: From enrollment to the end of treatment at 12 weeks
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