跳至主要内容
临床试验/NCT04649632
NCT04649632已完成不适用

Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.

Ipsen1 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2020年4月29日最近更新:
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
451
试验地点
1
主要终点
Dosing of botulinum toxin-A in daily practice in relation to time to next injection

研究概览

简要总结

Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox

排除标准

  • A patient will be excluded if he has been only treated with Xeomin

结局指标

主要结局

Dosing of botulinum toxin-A in daily practice in relation to time to next injection

时间窗: From baseline up to end of data collection (January 2012 up to December 2016)

Mean time to next injection per brand

时间窗: From baseline up to end of data collection (January 2012 up to December 2016)

Median time to next injection per brand

时间窗: From baseline up to end of data collection (January 2012 up to December 2016)

次要结局

  • Time interval between 2 injections of the same brand(From baseline up to end of data collection (January 2012 up to December 2016))
  • Average cost per year per brand per patient(From baseline up to end of data collection (January 2012 up to December 2016))
  • Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments(From baseline up to end of data collection (January 2012 up to December 2016))

研究者

发起方
Ipsen
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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