NCT00050947已完成3 期
A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Monotherapy in Pediatric Patients With Inadequately-controlled Partial Seizures.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 31
- 主要终点
- Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
研究概览
简要总结
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •To enter this study, patients must:
- •Have a diagnosis of partial seizures
- •Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication
- •Be willing to be hospitalized for up to 5 days
- •Weigh a minimum of 6.6 lbs
- •Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease
- •Have normal laboratory results
排除标准
- •To enter this study, a patient must not have or be:
- •Seizures caused by metabolic disturbance, toxic exposure, or active infection
- •A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures)
- •A history of status epilepticus within 30 days
- •Seizures not related to epilepsy
- •This study has some AED restrictions
- •Serum sodium levels <135 mEq/L
- •Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy
- •A history of chronic infection (e.g., hepatitis or HIV)
- •Significant electrocardiogram (ECG) abnormalities
- •A nursing mother taking anti-convulsant drugs
- •A history of substance abuse (including alcohol)
- •Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
- •Used experimental medication within 30 days of entering this study
结局指标
主要结局
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
次要结局
- Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase
研究者
研究点 (31)
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