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临床试验/NCT00210821
NCT00210821已完成3 期

A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.0 个研究点目标入组 347 人开始时间: 2004年2月最近更新:
适应症
相关药物

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

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

研究者

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