A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for 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
- 116
- 试验地点
- 22
- 主要终点
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
研究概览
简要总结
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
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
- •Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
- •TWSTRS severity, disability and total scores meeting the defined criteria at baseline
排除标准
- •Pure anterocollis or pure retrocollis
- •In apparent remission from cervical dystonia
- •Previous poor response to the last two botulinum toxin type A or type B treatments
- •Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
研究组 & 干预措施
1
Drug: abobotulinumtoxinA (Dysport®)
干预措施: Botulinum toxin type A (Biological)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
时间窗: Baseline and Week 4
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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
次要结局
- Subject VAS for CD Symptom Assessment(Baseline and week 12)
- SF-36 Physical Health Summary Score(Week 8)
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score(Baseline and Week 12)
- Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment(Baseline and Week 4)
- Investigator VAS for CD Symptom Assessment(Baseline and Week 4)
- Investigator's VAS for CD Symptom Assessment(Baseline and week 12)
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)(Baseline and Week 8)
- SF-36 Mental Health Summary Score(Week 8)
- Number of Participants Considered by the Investigator to be Overall Treatment Successes(Week 12)