A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 主要终点
- Change from baseline in the average monthly migraine episode rate.
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines. The antidepressant amitriptyline has been used successfully to prevent migraine headaches.
详细描述
People who suffer from migraines have many prescription medications to choose from, both to treat the migraine and to prevent it from starting. However, many patients have not had success in finding the drug that helps them best. Amitriptyline, an antidepressant, has been used successfully for many years to prevent migraine headaches. This study will compare the effectiveness of amitriptyline with the effectiveness of topiramate, an anti-seizure drug, in preventing migraines. The safety of both drugs will also be assessed. The objective of the study is to demonstrate that topiramate will be at least as effective as amitriptyline in preventing migraines. During the first 4 weeks of the study, topiramate or amitriptyline will be increased by 25 mg per week up to a total dose of 100 mg per day or up to the maximum tolerated dose, whichever is less. Treatment will continue at 100 mg per day for 22 weeks.
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
- •Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months
- •no more than 15 headache days in the previous month before study start
- •no heart rhythm problems or neurologic problems
- •women must not be pregnant and must use birth control
排除标准
- •Cannot have failed at least 2 previous trials of migraine prevention drugs
- •cannot have failed a previous trial of topiramate or amitriptyline
- •no cluster headaches
- •no migraine with aura without headache
- •no pain that is worse than the migraine pain
结局指标
主要结局
Change from baseline in the average monthly migraine episode rate.
次要结局
- Change in average monthly rate of days with migraine headache; change in average monthly rate of headache (migraine & non-migraine) days; change in average monthly rate of acute abortive medications; weight changes; quality of life assessments
