NCT00634985已完成4 期
A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点目标入组 120 人开始时间: 2002年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Functional response post-treatment
研究概览
简要总结
To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met International Headache Society diagnostic criteria for migraine with or without aura
- •Expected to suffer one to six acute migraine attacks per month based on past history
- •Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs
排除标准
- •Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
- •Atypical migraines that consistently failed to respond to adequate medical therapy
- •Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
研究组 & 干预措施
A
Experimental
干预措施: eletriptan (Drug)
结局指标
主要结局
Functional response post-treatment
时间窗: 2 hours
Headache severity and response post-treatment
时间窗: 2 hours
次要结局
- Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment(1, 2, 4, and 24 hours)
- Subject satisfaction post-treatment(2 and 24 hours)
- Vital signs(Week 12)
- Headache severity and response at baseline and post-treatment(1, 4 and 24 hours)
- Migraine recurrence post-treatment(1, 2, 4, and 24 hours)
- Subject preference and acceptability post-treatment(24 hours and 12 weeks)
- Adverse events(Week 12)
- Electrocardiogram(Week 12)
- Functional impairment severity and response at baseline and post-treatment(1, 4 and 24 hours)
- Time loss (from normal activities and from work) post-treatment(24 hours)
- Physical examination(Week 12)
研究者
研究点 (1)
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