Safety and Efficacy of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Children Aged 1 Month to 14 Years With Newly Diagnosed Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Cessation of seizures
研究概览
简要总结
Despite increasing clinical use of both agents, there is a paucity of head-to-head comparative data on the safety and efficacy of brivaracetam versus levetiracetam as initial monotherapy in children. The present study was therefore designed to compare the safety and efficacy of oral brivaracetam and levetiracetam as monotherapy in children aged one month to 14 years with newly diagnosed epilepsy.
详细描述
Most existing studies have focused on adjunctive use or refractory epilepsy, while evidence in treatment-naïve pediatric populations remains sparse. Addressing this gap is critical, as early and effective seizure control can substantially influence long-term neurodevelopmental outcomes. By evaluating seizure outcomes, tolerability, and adverse effect profiles, this study aims to provide evidence to guide clinicians in selecting the most appropriate first-line anti-seizure medication (ASM) for pediatric patients.
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
- None
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender
- •Aged 1 month to 14 years
- •With a clinical diagnosis of newly diagnosed epilepsy
排除标准
- •History of prior use of long-term antiseizure medications
- •Evidence of progressive neurological disease
- •Metabolic abnormalities
- •Structural brain malformations
- •Incompatible with monotherapy
- •Severe systemic comorbidities
研究组 & 干预措施
Brivaracetam group
Patients were given oral brivaracetam in a dose of 1-2 mg/kg/day in two divided doses, titrated to a maximum of 5 mg/kg/day based on clinical response and tolerability.
干预措施: Brivaracetam (Drug)
Levetiracetam group
Oral levetiracetam was initiated at a dose of 10-20 mg/kg/day in two divided doses, with gradual escalation up to 60 mg/kg/day if needed.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Cessation of seizures
时间窗: Up to 3 months
Cessation of seizures was labeled "yes" when a patient remained seizure free.
次要结局
- Adverse events(Up to 3 months)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research