NCT00639249已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Phase IIa Study of Safety and Motor Function Restoration in Subjects Treated With SA4503 Following Acute Ischemic Stroke
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
- 60
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.
详细描述
Further study details as provided by M's Science Corporation:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 years of age or older
- •Experienced a stroke from 48 to 72 hours before randomization
- •A total score of >/=4 on the NIHSS, or >/=2 on the upper or lower extremity motor scores of the NIHSS
- •Medically and neurologically stable within 24 hours prior to randomization
排除标准
- •Patients with transient ischemic attack
- •Patients with stroke in progression
- •Unstable cardiac, hepatic, or renal disease, or other major medical disorder
研究组 & 干预措施
P
Placebo Comparator
Placebo
干预措施: placebo (Drug)
A1
Experimental
SA4503
干预措施: SA4503 Low (Drug)
A2
Experimental
SA4503
干预措施: SA4503 High (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 4 weeks
次要结局
- NIHSS(4 weeks)
研究者
研究点 (1)
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