NCT00833196已完成不适用
An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 404
- 试验地点
- 36
- 主要终点
- Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
研究概览
简要总结
A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Idiopathic cervical dystonia
- •TWSTRS severity score ≥ 15
- •At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion
- •Written informed consent prior to collect the data
排除标准
- •Contraindications to any BoNT-A preparations
- •Secondary cervical dystonia
- •Subject already been included in the study
结局指标
主要结局
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
时间窗: Around 4 weeks post injection
次要结局
- To describe subject and investigator's CGI scores(Around 4 weeks post injection)
- To describe TWSTRS change scores from inclusion (total score & subscales scores)(Baseline, and around 4 weeks and 3 months post injection)
- To describe tremor change score from inclusion (TSUI scale)(Baseline, and around 4 weeks and 3 months post injection)
- To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion(Baseline, and around 4 weeks post injection)
- To identify prognostic factors for response (Exploratory Objective)(baseline, and around 4 weeks and 3 months post injection)
研究者
研究点 (36)
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