NCT00061022已完成3 期
SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,200
- 试验地点
- 256
- 主要终点
- Global disability on modified Rankin scale at 90 days.
研究概览
简要总结
This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
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 and females
- •Acute ischemic stroke with limb weakness
- •Onset of symptoms within 6 hours
- •Full functional independence prior to the present stroke
排除标准
- •Unconsciousness
- •Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
- •Severe illness with life expectancy less than 6 months.
- •Known severe kidney disorder.
- •Current known alcohol or illicit drug abuse or dependence.
- •Pregnant or breast-feeding.
- •Treatment with acetazolamide and methotrexate is not permitted during the infusion
- •Participation in a previous clinical study within 30 days.
- •Meets all other exclusion criteria.
结局指标
主要结局
Global disability on modified Rankin scale at 90 days.
次要结局
- NIH stroke scale
- Barthel Index
- Stroke Impact Scale
- EQ-5D all at 90 days
- Safety outcomes
研究者
研究点 (256)
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