A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 108
- 试验地点
- 34
- 主要终点
- Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
研究概览
简要总结
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
- •Returned to pre-treatment status as judged by the Investigator
排除标准
- •Pure anterocollis or pure retrocollis
- •Known antibodies to botulinum toxin type A
- •Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
- •Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
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
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.
次要结局
- Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score 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)
- Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline(Week 4 follow-up visit)