A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)

Ipsen0 个研究点目标入组 372 人开始时间: 2012年7月最近更新: 2019年1月14日

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: 372
主要终点: Change in Tsui scores

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.

研究设计

研究类型: Observational
观察模型: Case Control
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

•Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
•Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
•With the intention to be treated with Dysport®

排除标准

•The subject has already been included in this study
•Participation in an interventional trial
•Suffering from anterocollis or retrocollis as primary component

结局指标

主要结局

Change in Tsui scores

时间窗: Baseline and 12 weeks post-injection Cycle 2

The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

次要结局

Change in Tsui scores(Baseline and 12 weeks post-injection Cycle 4)

研究者

发起方

Ipsen

申办方类型

Industry

责任方

Sponsor

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