Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
- Conditions
- Migraine Disorders
- Interventions
- Registration Number
- NCT00604812
- Lead Sponsor
- Organon and Co
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel A Rizatriptan rizatriptan benzoate (5 mg) 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. Panel A Placebo Rizatriptan 5 mg 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. Panel B Rizatriptan rizatriptan benzoate (10 mg) 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. Panel B Placebo Rizatriptan 10 mg 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. Panel C Rizatriptan rizatriptan benzoate (5 mg) 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. Panel C Rizatriptan rizatriptan benzoate (10 mg) 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. Panel C Placebo Rizatriptan 10 mg 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. Panel C Placebo Rizatriptan 5 mg 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.
- Primary Outcome Measures
Name Time Method Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs 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)
- Secondary Outcome Measures
Name Time Method Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) 24 Hours Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax) 24 Hours Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax) 24 Hours Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½) 24 Hours Preliminary pharmacokinetics data; Apparent half-life (t½)