NCT00276315已完成3 期
A Phase III, Multicentre, Randomised, Assessor-blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 332
- 试验地点
- 6
- 主要终点
- Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
研究概览
简要总结
To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
- •Cohen scale ≥ to grade II
排除标准
- •Botulinum toxin type A treatment history within last 16 weeks prior to visit 1
- •Hemifacial spasm secondary to facial palsy
- •Previous alcohol or phenol injections or surgical therapy of the facial muscles
- •Requirement for botulinum toxin injection to site(s) of the body other than in this study
结局指标
主要结局
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
时间窗: At the end of week 4
次要结局
- Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)(At the end of week 1 and 12)
- Improvement degree of spasm (Jankovic scale)(At the end of week 1, 4 and 12)
- Assessment of efficacy by the subjects(At the end of week 1, 4 and 12)
研究者
研究点 (6)
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