A Randomized, Triple-Blind, Double-Dummy, Placebo-Controlled, Parallel Groups, Outpatient Study to Examine the Safety and Efficacy of MK0462 10 mg p.o. and MK0462 5 mg p.o. for the Treatment of Acute Migraine and Migraine Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,473
- 主要终点
- Pain Relief at 2 Hours After the Initial Dose of Test Drug
研究概览
简要总结
A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.
The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.
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
Rizatriptan 10 mg
干预措施: rizatriptan benzoate (MK0462) (Drug)
Rizatriptan 5 mg
干预措施: rizatriptan benzoate (MK0462) (Drug)
结局指标
主要结局
Pain Relief at 2 Hours After the Initial Dose of Test Drug
时间窗: 2 hours after initial dose of test drug
Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.
次要结局
- Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug(2 hours after initial dose of test drug)
- Pain Relief 2 Hours After Treatment for Headache Recurrence(2 hours after treatment for recurrence)
- No Disability at 2 Hours After the Initial Dose of Test Drug(2 hours after initial dose of test drug)
- Pain Free at 2 Hours After the Initial Dose of Test Drug(2 hours after initial dose of test drug)