NCT00651729已完成2 期
Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 279
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically stable poststroke patients with spastic muscles in the upper limb
排除标准
- •Stroke within 6 months of study enrollment
- •Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998
结局指标
主要结局
Adverse events
时间窗: Week 54
次要结局
- Spasticity as measured by the Ashworth scale(Week 54)
研究者
研究点 (2)
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