A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
研究概览
简要总结
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.
After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
- •Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
- •Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration
排除标准
- •Subject has no history of migraine headaches
- •Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
- •Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study
研究组 & 干预措施
Panel A Rizatriptan
Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A.
干预措施: rizatriptan benzoate (5 mg) (Drug)
Panel A Placebo
Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A.
干预措施: Rizatriptan 5 mg Placebo (Drug)
Panel B Rizatriptan
Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B.
干预措施: rizatriptan benzoate (10 mg) (Drug)
Panel B Placebo
Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B.
干预措施: Rizatriptan 10 mg Placebo (Drug)
Panel C Rizatriptan
Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
干预措施: rizatriptan benzoate (5 mg) (Drug)
Panel C Rizatriptan
Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
干预措施: rizatriptan benzoate (10 mg) (Drug)
Panel C Placebo
Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
干预措施: Rizatriptan 5 mg Placebo (Drug)
Panel C Placebo
Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
干预措施: Rizatriptan 10 mg Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
时间窗: 24 Hours
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)
次要结局
- Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)(24 Hours)
- Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))(24 Hours)
- Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)(24 Hours)
- Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)(24 Hours)