NCT00275912已完成4 期
A 24-week Prospective Open-label Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Frequency of epileptic episodes according to patient's diary
研究概览
简要总结
This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females, 6 months - 17 years of age;
- •diagnosis of epilepsy, partial seizures;
- •ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy
排除标准
- •progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
- •non-epileptic seizures;
- •drug or alcohol dependence during a year prior to screening;
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Frequency of epileptic episodes according to patient's diary
Electrocardiogram analysis for rhythm and conduction
Epileptic activity at electroencephalography in rest
Flash light and hyperventilation test with electroencephalography
Blood test for sodium, hepatic enzymes and blood cells
次要结局
- Rate of patients requiring additional antiepileptic drugs
- Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures
- Rate of patients with total and partial control of epilepsy
研究者
研究点 (10)
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