NCT00422422已完成2 期
Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy
适应症
干预措施
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
- 100
- 试验地点
- 39
- 主要终点
- Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
研究概览
简要总结
Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of epilepsy
- •Subject having at least 1 seizure (any type) during the 3 weeks before first visit
- •Stable dosing of 1-3 concomitant antiepileptic drugs
排除标准
- •Pregnant or nursing females
- •Concomitant use of Levetiracetam
- •Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
- •History of status epilepticus
- •Clinically significant acute or chronic illness, underlying disease or medication condition
- •History of suicide attempt
研究组 & 干预措施
Brivaracetam
Experimental
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
时间窗: Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
时间窗: Day 21
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
时间窗: Day 21
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
时间窗: Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
时间窗: Day 21
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
时间窗: Day 21
次要结局
- Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period(Baseline to end of the 3-week evaluation period)
- Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period(Baseline to end of the 3-week evaluation period)
- Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period(Baseline to the end of the 3-week evaluation period)
研究者
研究点 (39)
Loading locations...
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