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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study

Primary:

• To assess the safety and tolerability of single doses of MK0462 in pediatric migraineurs 5 Weeks Yes

Secondary:

• To obtain preliminary pharmacokinetic data following single dose administration of MK0462 5 Weeks No

Inclusion Criteria:

• Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
• Patient 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

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 23, 2008

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

Study ID Number: 2007_601

ClinicalTrials.gov Identifier: NCT00604812

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

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