NCT00807989已完成4 期
An Open Label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies (Phase Ⅳ)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Retention Rate After 52 Weeks Maintenance Period
研究概览
简要总结
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.
详细描述
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥16yr old
- •Who are diagnosed as epilepsy definitely
- •Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
- •Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
- •Who is not pregnant
- •Who can report seizure diary by him/herself or caregiver
- •Who agree to this trial and provide informed consent.
- •Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;
排除标准
- •Who has progressive CNS disease.
- •Has serious systemic or psychiatric disease
- •Who is not suitable by investigator(uncooperative)
- •Who can not fill up diary check card
- •Is pregnant, breastfeeding, or planning to become pregnant
- •Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
- •Who cancels to agree to this trial and provide informed consent.
- •ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
- •WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
- •Who took investigation products before participating this study
研究组 & 干预措施
Carbamazepine
Active Comparator
Carbamazepine
干预措施: Carbamazepine (Drug)
Lamotrigine/Valproate
Experimental
Lamotrigine and Valproate combination therapy
干预措施: Lamotrigine/Valproate (Drug)
结局指标
主要结局
Retention Rate After 52 Weeks Maintenance Period
时间窗: 52 weeks
\* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
次要结局
- Seizure Free Rate for 24 Weeks at Initial Target Dose(24 weeks)
- Seizure Free Rate for 52 Weeks at Initial Target Dose(52 weeks)
研究者
研究点 (1)
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