jRCT2080224879已完成2 期
A Phase 2, Double-blind Study of S-005151 in Patients with Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, randomized, double-blind, placebo-controlled, parallel-group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 60age old over 至 84age old under（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria
- •Patients diagnosed with supratentorial ischemic stroke on magnetic resonance imaging (MRI)
- •Patients who can be enrolled within 24 hours from 4.5 hours after the onset of ischemic stroke
- •Patients with neurologic signs corresponding to 8-22 on the National Institute of Health Stroke Scale (NIHSS) score and who have not experienced a rapid change in neurologic signs within 30 minutes before enrollment
排除标准
- •Main Exclusion Criteria
- •Patients with a disability corresponding to mRS score of >=2 before the onset of ischemic stroke
- •Patients who have undergone thrombolysis or intravascular recanalization therapy within 90 days before obtaining informed consent.
- •Patients with a history of stroke or intracranial hemorrhage that caused neurological events within 90 days before obtaining informed consent.
- •Patients diagnosed with a transient ischemic attack
- •Patients who cannot have MRI
结局指标
主要结局
-
efficacy mRS 90 days after the first dose
次要结局
- Adverse events
- Vital signs
- Electrocardiogram
- Clinical laboratory tests
- mRS at each visit other than day 90(each visit other than day 90)
- Proportion of subjects with mRS of <=1(each visit)
- Proportion of subjects with mRS of <=2(each visit)
- Proportion of subjects with mRS of 5 or 6(each visit)
研究者
研究点 (1)
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