NCT02877615已完成2 期
Randomized Efficacy and Safety Trial With Oral S 44819 After Recent Ischemic Cerebral Event. International, Multi-centre, Randomized, Doubleblind Placebo-controlled Phase II Study. (RESTORE BRAIN Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 121
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.
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 85 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
S 44819 150 mg twice a day
Experimental
干预措施: S 44819 150 mg twice a day (Drug)
S 44819 300 mg twice a day
Experimental
干预措施: S 44819 300 mg twice a day (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: Up to 90 days
次要结局
- 12 lead-ECG(Day 0 Day 5 Day 30 Day 60 Day 90 Day 105)
- Montreal Cognitive Assessment scale (Moca) total score(Day 30 Day 90)
- Trail Making Test (TMT) time for part A(Day 30 Day 90)
- Trail Making Test (TMT) time for part B(Day 30 Day 90)
- National Institutes of Health Stroke Scale (NIHSS) total score(Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105)
- Barthel Index (BI) total score(Day 30 Day 60 Day 90 Day 105)
- Adverse events(Through study completion, an average of 3 months)
- Body weight(Selection visit Day 30 Day 60 Day 90 Day 105)
- Vital signs (supine for Systolic and Diastolic Blood Pressure)(Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105)
- Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS)(Day 5 Day 30 Day 60 Day 90 Day 105)
研究者
研究点 (121)
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