NCT00043914已完成4 期
A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Drug levels of lamotrigine.
研究概览
简要总结
This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years old or older.
- •Have confident diagnosis of epilepsy.
- •Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
- •Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.
排除标准
- •A history of hypersensitivity to the drug being studied.
- •Currently being treated with or has been treated in the past with the drug being studied.
- •Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
- •If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
- •Has taken an investigational drug or the medication Felbatol within the previous 30 days.
- •Is abusing alcohol and/or other substances.
结局指标
主要结局
Drug levels of lamotrigine.
次要结局
- This study has no secondary outcome measures.
研究者
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