NCT03216473已完成3 期
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Essential Blepharospasm
Medy-Tox0 个研究点目标入组 140 人开始时间: 2016年5月25日最近更新:
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
- 140
- 主要终点
- JRS (Jankovic Rating Scale) sum-score
研究概览
简要总结
This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.
详细描述
Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with essential blepharospasm.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 75
- •Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection
排除标准
- •Subjects who underwent surgical operation
- •Subjects with Neuroleptic induced blepharospasm
研究组 & 干预措施
Neuronox
Experimental
Botulinum Toxin Type A for injection
干预措施: Neuronox (Drug)
Botox
Active Comparator
Botulinum Toxin Type A for injection
干预措施: Botox (Drug)
结局指标
主要结局
JRS (Jankovic Rating Scale) sum-score
时间窗: From baseline at 4 week
Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score
次要结局
未报告次要终点
研究者
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