A Phase IIa, Multicenter, Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 660
- 主要终点
- Percentage of Participants Who Experienced an Adverse Event
研究概览
简要总结
A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic 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 is 18 years of age or older
- •Patient has had a history of migraine with or without aura
- •Patient is able to complete study questionnaire(s) and paper diary
排除标准
- •Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
- •Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
- •Patient was older than 50 years of age at migraine onset
- •History of gastric or small intestinal surgery or has a disease that causes malabsorption
- •Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
- •Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
- •Currently participating in a study with MK-0974 or MK-3207
研究组 & 干预措施
Telcagepant 140 mg
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
干预措施: Telcagepant 140 mg (Drug)
Placebo
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
干预措施: 280 mg telcagepant placebo (Drug)
Telcagepant 140 mg
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
干预措施: 280 mg telcagepant placebo (Drug)
Telcagepant 280 mg
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
干预措施: Telcagepant 280 mg (Drug)
Telcagepant 280 mg
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
干预措施: 140 mg telcagepant placebo (Drug)
Placebo
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
干预措施: 140 mg telcagepant placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced an Adverse Event
时间窗: up to 14 days after last dose of study drug (up to 12 weeks)
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.
Change From Baseline in Mean Monthly Headache Days
时间窗: Baseline and Week 12
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.
Change From Baseline in Mean Monthly Migraine Days
时间窗: Baseline and Week 12
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.
Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event
时间窗: up to 12 weeks
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.
次要结局
- Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days(Week 12)
- Change From Baseline in the Mean Monthly Migraine Attacks(Baseline and Week 12)
- Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication(Baseline and Week 12)