NCT03232320已完成3 期
A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia
Medy-Tox1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年7月6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
- 66
- 试验地点
- 1
- 主要终点
- Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
研究概览
简要总结
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
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
- •Male or female aged 20 to less than 75 years
- •Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10
排除标准
- •Subjects with pure anterocollis
- •Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
- •A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
- •Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study
研究组 & 干预措施
MEDITOXIN
Experimental
干预措施: Meditoxin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
时间窗: week 4 follow-up visit
次要结局
- Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline(week 4 follow-up visit)
- Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline(week 4 follow-up visit)
- Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline(week 4 follow-up visit)
研究者
研究点 (1)
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