NCT00896987已完成4 期
An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
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
- 121
- 试验地点
- 1
- 主要终点
- To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
研究概览
简要总结
The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100 patients.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 16~60
- •Seizure type was defined by MRI etc.
- •Had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in EEG or brain imaging)
- •Need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before)
- •Is not pregnant by pregnancy test and is using contraceptive method
- •Can report seizure diary by him/herself or his/her sick nurse
- •Agreed to trial by written consent
排除标准
- •Follow-up loss
- •Canceled agreement
- •Added other medication due to aggravated disease in 24 weeks
- •Diagnosed as IGE
- •Has progressive CNS disease by MRI or EEG
- •Has serious systemic or psychological disease
- •Under IQ 70
- •Baseline lad data abnormality: Creatinine 2.0mg/dl or GOT/GPT 2 times higher than normal
- •Abuse experience on alcohol or drugs
- •Has experience on serious adverse event of any drug
- •Previous experience on lamotrigine or carbamazepine
- •Not suitable patients by investigator (uncooperative)
- •Other reason which may interrupt the trial
研究组 & 干预措施
1
Experimental
lamotrigine
干预措施: lamotrigine (Lamictal) (Drug)
2
Active Comparator
carbamazepine
干预措施: Carbamazepine (Tegretol) (Drug)
结局指标
主要结局
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
时间窗: 48 weeks
次要结局
- Seizure outcome and tolerability(48 weeks)
研究者
研究点 (1)
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