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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 26
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Strengths of solriamfetol (JZP-110) strengths: 37.5 mg，75 mg, 150 mg
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.
干预措施: Solriamfetol (Drug)
matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
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)
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)