NCT00050934已完成3 期
A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy 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
- 132
- 试验地点
- 31
- 主要终点
- change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
研究概览
简要总结
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy 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 3 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
- •Be willing to be hospitalized
- •Weigh a minimum of 6.6 pounds
- •Be taking a stable dose of one to two concomitant anti-epileptic medications
- •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
- •Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam)
- •Taking felbamate within 6 months
- •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
- •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
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
次要结局
- % change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).
研究者
研究点 (31)
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