NCT00646711已完成2 期
A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients 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
- Abbott
- 入组人数
- 16
- 主要终点
- Number of seizures
研究概览
简要总结
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator.
- •Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization.
- •Minimum body weight of 37 lbs.
排除标准
- •Six-month history of drug or alcohol abuse.
- •Status epilepticus within 6 months prior to screening.
- •Abnormal platelet or ALT/AST levels.
研究组 & 干预措施
Sequence Group I
Experimental
Depakote Delayed Release/Depakote Sprinkle
干预措施: Depakote Delayed-Release/Depakote Sprinkle (Drug)
Sequence Group II
Experimental
Depakote ER
干预措施: Depakote ER (Drug)
结局指标
主要结局
Number of seizures
时间窗: 2 weeks
Number of Adverse Events
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
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