Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: rizatriptan benzoate (5 mg)
  • A single dose of rizatriptan 5 mg administered on Day 1.
• Drug: rizatriptan benzoate (10 mg)
  • A single dose of rizatriptan 10 mg administered on Day 1.
• Drug: Rizatriptan 5 mg Placebo
  • A single dose of rizatriptan 5 mg placebo administered on Day 1.
• Drug: Rizatriptan 10 mg Placebo
  • A single dose of rizatriptan 10 mg placebo administered on Day 1.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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.
• Placebo Comparator: 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.
• Experimental: 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.
• Placebo Comparator: 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.
• Experimental: 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.
• Placebo Comparator: 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.

Primary Measures

• Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
  • Time Frame: 24 Hours
    Safety Issue?: Yes

Secondary Measures

• Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))
  • Time Frame: 24 Hours
    Safety Issue?: No
• Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)
  • Time Frame: 24 Hours
    Safety Issue?: No
• Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)
  • Time Frame: 24 Hours
    Safety Issue?: No
• Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
  • Time Frame: 24 Hours
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604812

Study ID Number: MK-0462-083

ClinicalTrials.gov Identifier: NCT00604812

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site