A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- rate of adverse event
研究概览
简要总结
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of aged over 19 years
- •Subjects diagnosed with primary cervical dystonia
排除标准
- •Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
- •Pregnant or nursing
- •Females or males who do not agree on proper contraceptive measure
研究组 & 干预措施
Botulax®
干预措施: Botulinum toxin type A injection (Drug)
Botox®
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
结局指标
主要结局
rate of adverse event
时间窗: 12 weeks (during the clinical trial)
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.
Change From Baseline in the Total Score of the TWSTRS score.
时间窗: Baseline to Week 4 , Week 8, Week 12
The average of the change from baseline in TWSTRS-total score at Weeks 4, 8 and 12 will be determined. full name of TWSTRS is Toronto Western Spasmodic Torticollis Rating Scale. The validated assessment scale TWSTRS is consists of 3 sub-scales. 1. severity (0\~35 points) 2. pain (0\~20 points) 3. disability( 0\~30 points) Total score ranges from 0 to 85 points.
次要结局
未报告次要终点