Efficacy of Pregabalin in Migraine Prevention
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- days with migraine
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.
详细描述
The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.
- •Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.
- •Available for follow-up at least 9 months.
排除标准
- •Patients with headache others than migraine.
- •Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.
- •Prophylactic drugs for migraine 12 weeks before randomization.
- •Onset of migraine occurred after 50 years.
- •Hypersensitivity to pregabalin or sodium valproate.
结局指标
主要结局
days with migraine
次要结局
- hours with migraine
- headache severity index
- level of disability
- reports of adverse events