NCT02947815已完成2 期
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase II/III Clinical Trial to Compare the Safety and Efficacy of NABOTA Versus BOTOX in Treatment of Essential Blepharospasm
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- The change from baseline in Scott's Scale Score
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male of female of at least 18 years old
- •Grade 2~4 in Scott's scale
排除标准
- 未提供
研究组 & 干预措施
NABOTA
Experimental
Single-dose
干预措施: Clostridium Botulinum Toxin Type A (Drug)
BOTOX
Active Comparator
Single-dose
干预措施: Clostridium Botulinum Toxin Type A (Drug)
结局指标
主要结局
The change from baseline in Scott's Scale Score
时间窗: At 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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