NCT00544050已完成2 期
An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 13
- 主要终点
- PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
研究概览
简要总结
The primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month to less than 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female between 1 month and less than 4 years
- •diagnosis of any type of epilepsy
- •at least 5 kg body weight
- •using no more than two antieplieptic drugs
排除标准
- •a treatable seizure etiology
- •epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease
- •history of status epilepticus during the 2 weeks prior to the Selection Visit
- •history of or the presence of pseudoseizures
- •epilepsy surgery within one year prior to the Selection Visit
- •on a ketogenic diet
- •taking felbamate at the Selection Visit
结局指标
主要结局
PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
次要结局
未报告次要终点
研究者
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