Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,959
- 主要终点
- Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
研究概览
简要总结
This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.
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
- Single (Participant)
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
- •Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
- •History of migraine headache
排除标准
- 未提供
研究组 & 干预措施
Rizatriptan 5 mg
Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
干预措施: Rizatriptan 5 mg (Drug)
Rizatriptan 10 mg
Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
干预措施: Rizatriptan 10 mg (Drug)
Standard Care
Standard care at onset of migraine attack
干预措施: Standard Care (Drug)
结局指标
主要结局
Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
时间窗: 2 hours after initial dose of test drug
Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.
Number of Participants With Serious Clinical Adverse Experiences
时间窗: Up to 12 months
Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants With Drug-related Clinical Adverse Experiences
时间窗: Up to 12 months
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Number of Participants Who Discontinued Due to Clinical Adverse Experiences
时间窗: Up to 12 months
Number of Participants With Drug-related Lab Adverse Experiences
时间窗: Up to 12 weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE). A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
次要结局
未报告次要终点