NCT00109083已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 24
- 主要终点
- Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
研究概览
简要总结
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.
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
- 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
- •Established history of migraines for at least 1 year;
- •Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
- •Migraines must have first started before age 50.
排除标准
- •Most frequent headache type is not migraine;
- •Failed 3 or more studies of effective migraine-preventing medications;
- •Overuse of pain medications to treat migraines;
- •Not willing to stop use of migraine-preventing medications;
- •Significant serious concomitant diseases.
结局指标
主要结局
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
次要结局
未报告次要终点
研究者
研究点 (24)
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