CTRI/2017/12/010835招募中4 期
Therapeutic drug monitoring of levetiracetam to individualize drug therapy in patients with epilepsy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- KEM Hospital
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Seizure control
研究概览
简要总结
Levetiracetam is a second line anti epileptic drug. In the last few years, its use has expanded considerably. However, very few centres estimate blood levels to individualize drug therapy in patients with epilepsy. Hence this study was planned to set up and validate a HPLC method for estimation of Levetiracetam and subsequently use Therapeutic Drug Monitoring to individualize treatment
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients on Levetiracetam for at least one year.
排除标准
- 未提供
结局指标
主要结局
Seizure control
时间窗: At one month, six months and one year when they come for blood level estimation
次要结局
- Proportion of patients with good seizure control, levels in patients with renal dysfunction(Monthly for the first six months after study initiation and six monthly subsequently)
研究者
研究点 (1)
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