NCT00043875已完成2 期
A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 66
- 主要终点
- The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
研究概览
简要总结
This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confident diagnosis of epilepsy
- •Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
- •Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
- •Have no underlying chronic metabolism problems
- •Have normal lab results
- •Have a normal electrocardiogram (ECG)
排除标准
- •Have a diagnosis of severe, progressive myoclonus.
- •Have seizures not related to epilepsy.
- •Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
- •Have progressive or unstable condition of the nervous system.
- •Used experimental medication within 30 of enrollment into the study.
- •Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
- •Current use of the medication felbamate.
- •Current use of adrenocorticotrophic hormone (ACTH).
- •Following a ketogenic diet.
- •Receiving vagal nerve stimulation (VNS).
结局指标
主要结局
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
时间窗: 36 Months
次要结局
- Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events(36 Months)
研究者
研究点 (66)
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