NCT00432549Unknown4 期
Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache
The New England Center for Headache, P.C.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain free days through day ninety
研究概览
简要总结
The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medication overuse headaches 18 years of age and older Must have a diagnosis of probable medication overuse headache Must have greater than fifteen headache days per month Must be in generally good health Female subjects must be postmenopausal or practicing an acceptable method of birth control
排除标准
- •Not overusing six or more tablets per day of compounds containing barbituates opioids No overuse of triptans Previous failure or side effects with topiramate or almotriptan Cannot be pregnant or lactating
结局指标
主要结局
Pain free days through day ninety
Primary for the prevention of relapse
Number of days with mild or no pain in the first two weeks of treatment
Primary measure for the detoxification period
次要结局
- Primary measure for the detoxification period
- Number of days without any headache in the first two weeks of treatment
- Primary for the prevention of relapse
- Headache frequency through day ninety
研究者
研究点 (2)
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