A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,703
- 主要终点
- Number of Patients Reporting Pain Freedom at 2 Hours Postdose
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has at least 1 year history of migraine (with or without aura)
- •Females of childbearing years must use acceptable contraception throughout trial
排除标准
- •Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
- •Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
- •Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- •Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
- •Patient has a history of cancer within the last 5 years
研究组 & 干预措施
MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
干预措施: MK0974 50 mg (Drug)
MK0974 150 mg
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
干预措施: MK0974 150 mg (Drug)
MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
干预措施: MK0974 300 mg (Drug)
结局指标
主要结局
Number of Patients Reporting Pain Freedom at 2 Hours Postdose
时间窗: 2 hours post dose
Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Number of Patients Reporting Pain Relief at 2 Hours Post Dose
时间窗: 2 hours post dose
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
时间窗: 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
时间窗: 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
时间窗: 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.
次要结局
- Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose(2 to 24 hours postdose)
- Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose(2 to 24 hours postdose)
- Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose(2 hours postdose)