A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 134
- 试验地点
- 42
- 主要终点
- Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
研究概览
简要总结
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
- •TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;
排除标准
- •In apparent remission from Cervical Dystonia
- •Diagnosis of pure retrocollis or pure anterocollis
- •For non-naïve subjects, previous poor response to either of the last two Botox treatments
- •Known requirement of <100U or >200U of Botox injected into the neck muscles
研究组 & 干预措施
Placebo
Placebo, up to 2mL
干预措施: Placebo (Drug)
Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
时间窗: 4 weeks post-treatment
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
次要结局
- Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.(4 weeks post-treatment)
- Change From Baseline in CDIP-58 Total Score at Week 2.(2 weeks post-treatment)
- Change From Baseline in TWSTRS Total Score at Week 2.(2 weeks post-treatment)
- Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.(2 weeks post-treatment)
- TWSTRS Responders at Week 2.(2 weeks post-treatment)
- Change From Baseline in CGIC in CD at Week 4.(4 weeks post-treatment)
- TWSTRS Responders at Week 4.(4 weeks post-treatment)