NCT00812006已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Pain Relief (PR)
研究概览
简要总结
This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
- •Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
- •Patient can distinguish between migraine and other types of headache
- •Patient agrees to remain abstinent or use effective birth control during the study
排除标准
- •Patient is pregnant or breast-feeding
- •Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
- •Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
- •Patient was > 50 years old at age of migraine onset
- •Patient has history of heart disease
- •Patient has uncontrolled hypertension
- •Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
- •Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
- •Patient is taking more than one other migraine prophylactic medication
- •Patient has repeatedly failed to respond to or tolerate rizatriptan
研究组 & 干预措施
A
Experimental
Treatment Sequence A: rizatriptan, rizatriptan, placebo
干预措施: rizatriptan benzoate (Drug)
B
Experimental
Sequence B: rizatriptan, placebo, rizatriptan
干预措施: rizatriptan benzoate (Drug)
C
Experimental
Sequence C: placebo, rizatriptan, rizatriptan
干预措施: rizatriptan benzoate (Drug)
结局指标
主要结局
Pain Relief (PR)
时间窗: 2 hours post dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.
次要结局
- Pain Freedom (PF)(2 hours post dose)
- Sustained Pain Relief (SPR)(2 - 24 hours post dose)
- Normal Rating of Functional Disability (NRFD)(2 hours post dose)
- Treatment Satisfaction (TS)(24 hours post dose)
研究者
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