NEWER VS OLDER ANTIEPILEPTIC DRUGS (AEDs) MONOTHERAPY IN PAEDIATRIC POPULATION – A COMPARATIVE OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- 1)Proportion of patients achieving seizure free days during period of study.
研究概览
简要总结
Epilepsy is a common chronic neurologic disorder that requires long term medication in children. In recent years many Anti Epileptic Drugs (AEDs) have been discovered. Adverse Drug Reactions (ADRs) are quite common due to AEDs and are common causes of treatment failure. Lack of seizure control and intolerable ADRs affect cognitive, emotional, social and physical functioning of children. There is lack of data on the efficacy and safety of newer AEDs.With the increase in use of New AEDs there is greater need to determine the effectiveness of these drugs in paediatric population. This study will aim to:
Ø- -To compare the efficacy of Newer (Levetiracetam, Topiramate, Oxcarbazepine etc) as well as Older (Phenytoin, Valproic Acid, Phenobarbitone etc ) AEDs as monotherapy in paediatric population.
Ø - To compare ADRs due to older and newer AEDs.
Ø - To assess the Quality Of Life (QOL) in paediatric population on AEDs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Epileptic patients aged between 2 – 12 years.
- •Patients prescribed monotherapy of AEDs. 3)Newly diagnosed patients of epilepsy.
- •Previously diagnosed and treatment failure patients.
- •Previously diagnosed and treated patients presenting with ADRs. 6)Patients having seizures due to drugs, any trauma or diseases.
- •Less than one seizure per year prior to treatment.
排除标准
- •Patients diagnosed with cryptogenic epilepsy.
- •Patients who are treated with more than one AED.
- •Drug resistant patients.
结局指标
主要结局
1)Proportion of patients achieving seizure free days during period of study.
时间窗: 1 year
2)Incidence, Prevalence and severity/seriousness of ADRs.
时间窗: 1 year
次要结局
- 1)Cognitive, emotional, social and physical functions(1 year)