Switching Between Different Types of Botulinum Toxin-A in Children With Cerebral Palsy Treated for Spasticity: a Safety Retrospective Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Occurence of treatment related adverse events
研究概览
简要总结
Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.
With this study investigators would like to evaluate retrospectively if switching from one toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin to another was maintained.
详细描述
A data base was designed to capture all data that were considered relevant to the treatment evaluation. The data were transcribed directly from participants medical records. For the purpose of the study, data from the two subsequent visits where a different type of toxin was given will be collected and evaluated . In order to collect the pre and post status in terms of safety and efficacy, for each participant, data corresponding to the 6 previous and posterior months after the switch of the toxin will also be collected or data corresponding to the previous and posterior visit after the switch of the toxin will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children diagnosis of cerebral palsy with respect to Rosenbaum criteria,
- •children having received repeated injections with two different types of toxinA treatment into their lower limb(s)
排除标准
- •children without repeated Botulinum toxin type A injections
- •children having received repeated injections with same type of toxinA
结局指标
主要结局
Occurence of treatment related adverse events
时间窗: Up to 30 months
Overall and per injection cycle
次要结局
- Observational Gait Scale(Up to 30 months)
- Modified Ashworth Scale(Up to 30 months)
- Tardieu Scale(Up to 30 months)
研究者
Nigar Dursun
Professor, MD
Kocaeli University