A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 473
- 主要终点
- Pain Relief at 2 Hours During the First Migraine Attack Period
研究概览
简要总结
A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.
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
- •Patient had at least a 6-month history of migraine, with or without aura
- •Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
- •Patient was judged to be in good health, apart from migraine
排除标准
- •Patient was pregnant or a nursing mother.
- •Patient had abused drugs or alcohol within 12 months prior to entering the study
- •Patient had a history of cardiovascular disease
- •Patient had clinically significant ECG abnormality
- •Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- •Patient received treatment with an investigational device or compound within 30 days of the study start
- •Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
- •Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- •Patient had prior exposure to rizatriptan
研究组 & 干预措施
Treatment Sequence 1
Placebo-Rizatriptan-Rizatriptan-Rizatriptan
干预措施: rizatriptan benzoate (Drug)
Treatment Sequence 2
Rizatriptan-Placebo-Rizatriptan-Rizatriptan
干预措施: rizatriptan benzoate (Drug)
Treatment Sequence 3
Rizatriptan-Rizatriptan-Placebo-Rizatriptan
干预措施: rizatriptan benzoate (Drug)
Treatment Sequence 4
Rizatriptan-Rizatriptan-Rizatriptan-Placebo
干预措施: rizatriptan benzoate (Drug)
Treatment Sequence 5
Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan
干预措施: rizatriptan benzoate (Drug)
结局指标
主要结局
Pain Relief at 2 Hours During the First Migraine Attack Period
时间窗: 2 hours
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
次要结局
- Pain Relief at 2 Hours During the Second Migraine Attack Period(2 hours)
- Pain Relief at 2 Hours During the Third Migraine Attack Period(2 hours)
- Pain Relief at 2 Hours During the Fourth Migraine Attack Period(2 hours)