NCT01239628终止不适用
A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- Documentation of the injection intervals
研究概览
简要总结
The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.
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
- •Subject able to comply with the protocol
- •Provision of written informed consent prior to collecting the data
- •Male or female patients of 18 years or older
- •Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated
排除标准
- •The subject has already been included in this survey
- •Patients who already received BoNT-A treatment for upper limb spasticity
- •Patients with known intolerance for BoNT-A
- •Subjects unable to comply with the protocol
结局指标
主要结局
Documentation of the injection intervals
时间窗: 3 years
Documentation of treatment modalities
时间窗: 3 years
次要结局
- Documentation of the main reason(s) for dose change(s)(3 years)
- Documentation of the main reason(s) for change in injection intervals(3 years)
- Documentation of the physician satisfaction with the treatment(3 years)
- Documentation of the patient satisfaction with the treatment(3 years)
研究者
研究点 (11)
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