NCT01945684已完成3 期
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- The change in MAS(Modified Ashworth Scale)grade for Wrist flexor
研究概览
简要总结
Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female adult patients
- •≥ 6 weeks since the last stroke
排除标准
- •1.Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis.
研究组 & 干预措施
Botulinum toxin type A (DWP450)
Experimental
DWP450: Botulinum toxin type A
干预措施: Botulinum toxin type A (Drug)
Botulinum toxin type A (Botox®)
Active Comparator
Botox®: Botulinum toxin type A
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
The change in MAS(Modified Ashworth Scale)grade for Wrist flexor
时间窗: at 4 week
The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone
次要结局
未报告次要终点
研究者
研究点 (1)
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