CTRI/2019/05/018990已完成Unknown
A comparative study of the safety, efficacy, quality of life outcome and pharmacoeconomics of levetiracetam with controlled-release carbamazepine in patients of new onset focal seizures
Institutional sponsored1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月5日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Minimal adverse drug reactions and seizure freedom
研究概览
简要总结
The study is being done to compare the safety, efficacy, quality of life outcome and pharmacoeconomics of levetiracetam with controlled-release carbamazepine in adult patients of new onset focal seizures.
The study will be a randomized, prospective, open label, comparative interventional study.
The study will be conducted in the Department of Neurology and the Department of Pharmacology at Dr. R.P.G.M.C, Kangra at Tanda which is a 500 bedded multispeciality tertiary health care centre situated in Himachal Pradesh in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The study will include all the newly diagnosed consenting adult patients of focal seizures without any other co-morbidities.
排除标准
- •Patients not willing to give written informed consent.
- •Pregnant females.
- •Patients already on treatment with study drugs.
- •Patients of seizures others than focal seizures.
- •Patients of head trauma within past one month.
- •Patients with known contraindication or refractoriness to study drugs.
结局指标
主要结局
Minimal adverse drug reactions and seizure freedom
时间窗: At 1 month, 3 months and 6 months
次要结局
- Quality of life outcome(Before initiating treatment and at 6 months)
- Pharmacoeconomics(At 6 months)
研究者
研究点 (1)
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