Open label randomised comparison of levetiracetam and sodium valproate monotherapy in childhood epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment will be considered successful if there is no repeat seizure activity for 6 months
研究概览
简要总结
Levetiracetam has proven efficacy in childhood epilepsy. Its intravenous use has been recommended in convulsive status epilepticus. Oral levetiracetam is safe and efficacious in various childhood epilepsies. Its use as monotherapy has been suggested for partial seizures and generalised tonic clonic seizures. There is still a need for well designed trials to justify the widespread use of levetiracetam monotherapy in children.
Objectives:
PrimaryTo compare the efficacy of levetiracetam and sodium valproate in childhood epilepsy by comparing repeat seizures for 6 months.
Secondary
1.To compare side effect profile of levetiracetam and valproate
2.To compare the retention rates of levetiracetam and valproate
3.To compare time to first repeat seizure
4.To compare drug levels at steady state (4 day for leveteracitam and 7th day for valproate).
STUDY SETTING
The study will be conducted in Department of Pediatrics, GTB hospital and Department of Neuropsycopharmacology, IHBAS, Delhi. An approval from the ethics committee will be obtained
PARTICIPANTS
Children aged 3 to 12 years presenting with newly diagnosed focal motor or generalized epilepsy
OUTCOME VARIABLES
Primary outcome variable-
Treatment will be considered successful if there is no repeat seizure activity for 6 months.
Secondary outcome variable-
- Side effects profile of the patients in each group
- Achievement of therapeutic drug levels at steady state and 6 months
- Time to first seizure after steady state of drug
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed focal motor or generalised epilepsy.
排除标准
- •1.Children who are on anti epileptic for more than 15 days 2.Children with congenital anomalies or developmental delay or microcephaly 3.Acute head trauma or post traumatic epilepsy.
结局指标
主要结局
Treatment will be considered successful if there is no repeat seizure activity for 6 months
时间窗: Treatment will be considered successful if there is no repeat seizure activity for 6 months
次要结局
- 1.Side effect profile of the patients in each group(2.Achievement of therapeutic drug levels at steady state and 6 months)