Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
研究概览
简要总结
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.
详细描述
The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.
The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK) samples for a maximum of 4 days;
For children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight:
- Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily);
- Children ≥ 6 months to < 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily).
The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 4 years of age, inclusive
- •The subject suffers from epilepsy (except status epilepticus)
- •The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time
排除标准
- •The subject has difficult venous accessibility
- •History of status epilepticus during the 3 months prior to Screening
- •The subject is on felbamate with less than 18 months continuous exposure before Screening.
- •The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.
研究组 & 干预措施
Levetiracetam
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
时间窗: Treatment period (up to 4 days)
次要结局
- Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)(Treatment period (up to 4 days))
- Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received(Treatment period (up to 4 days))