A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 主要终点
- Change in TWSTRS score
研究概览
简要总结
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.
详细描述
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 20 and
- •Patient who is diagnosed with primary cervical dystonia over 1 year.
- •Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
- •For patients with prior treatments of Botox®, over 12 weeks have passed.
- •Patients who voluntarily sign the informed consent
- •Patients who can comply with the study procedures and visit schedule
排除标准
- •Patient who has been diagnosed with pure anterocollis.
- •Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\
- •Severe respiratory function disorder or dysphasia
- •Allergy in Investigational Product.
- •Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
- •Investigator's decision.
研究组 & 干预措施
Meditoxin
Meditoxin administered 200U~300U, single-dose administration.
干预措施: Medytoxin (Biological)
Botox
Botox administered 200-300U, single-dose administration.
干预措施: Botox (Biological)
结局指标
主要结局
Change in TWSTRS score
时间窗: 1 month
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
次要结局
- Change in TWSTRS score(1, 2, 3 months)
- Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial(1, 2, 3 months)