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

• Status: Completed
• Trial end date: 2010-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Rizatriptan

Criteria

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