NCT00712725已完成2 期
A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 676
- 主要终点
- Pain Freedom (PF)
研究概览
简要总结
The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women from 18 to 65 years of age
- •1+ year history of migraine that typically last from 4 to 72 hours if untreated
- •Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
- •Not pregnant or planning to become pregnant in next 6 months
排除标准
- •Pregnant or breast-feeding, or planning to become pregnant in next 6 months
- •Cannot distinguish migraine attacks from tension type headaches
- •Migraines are mild or resolve without medication in less than 2 hours
- •More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
- •Basilar type or hemiplegic migraine headaches
- •More than 50 years old when migraines began
- •History of cardiovascular disorder within last 6 months
研究组 & 干预措施
2
Experimental
MK3207- 5 mg
干预措施: MK3207- 5 mg (Drug)
1
Experimental
MK3207- 2.5 mg
干预措施: MK3207- 2.5 mg (Drug)
3
Experimental
MK3207- 10 mg
干预措施: MK3207- 10 mg (Drug)
4
Experimental
MK3207- 20 mg
干预措施: MK3207- 20 mg (Drug)
5
Experimental
MK3207- 50 mg
干预措施: MK3207- 50 mg (Drug)
6
Experimental
MK3207- 100 mg
干预措施: MK3207- 100 mg (Drug)
结局指标
主要结局
Pain Freedom (PF)
时间窗: 2 hours postdose
Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain
次要结局
- Pain Relief (PR)(2 hours postdose)
- Absence of Photophobia(2 hours postdose)
- Absence of Phonophobia(2 hours postdose)
- Absence of Nausea(2 hours postdose)
- Sustained Pain Freedom (SPF)(2-24 hours postdose)
研究者
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