The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy
研究概览
简要总结
The primary aim of the study is to determine the effect of reducing the number and/or dose of anti epileptic drugs on an individual's quality of life and seizure control in people with difficult to control epilepsy and who are on polytherapy.
This is a randomised trial so children will be divided into two groups, with reduction of anti epileptic drugs in the first group (withdrawal group) and no change to their medications in the second (control group). Irrespective of the group the child is assigned to (withdrawal group or control group), we will ask parents to complete several questionnaires on 2 occasions: the first time will be immediately after the child enters the study (i.e. baseline assessment), and a second and last one will be 6 months after entering the study (i.e. follow-up assessment). These questionnaires aim to "quantify" aspects related with quality of life, AED side effects, seizure severity, and behaviour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young people aged 6-21 years with intractable epilepsy receiving antiepileptic drug polytherapy
排除标准
- 未提供
结局指标
主要结局
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy
时间窗: 6 months
次要结局
- Identify other determinants of quality of life in this group of subjects(6 months)