跳至主要内容
临床试验/NCT00210431
NCT00210431已完成不适用

A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)

Ipsen35 个研究点 分布在 3 个国家目标入组 783 人开始时间: 2004年10月最近更新:
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
783
试验地点
35
主要终点
- assessment of efficacy as assessed by treating physician at scheduled follow up visit

研究概览

简要总结

The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • adult or child over the age of 2 years
  • scheduled to receive Dysport as per their normal treatment practice, and in conformance with their country's Summary of Product Characteristics

排除标准

  • history of hypersensitivity to Dysport or drugs with a similar chemical structure
  • treatment with any other investigational drug within the last 30 days before survey entry

结局指标

主要结局

- assessment of efficacy as assessed by treating physician at scheduled follow up visit

- data on adverse events since treatment with Dysport

次要结局

未报告次要终点

研究者

发起方
Ipsen
申办方类型
Industry

研究点 (35)

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