Drug Study in Pediatric Subjects With Migraines

A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with...

Date First Received: October 17, 2007

Last Updated: January 31, 2008

Verified by: Merck, January 2008

Clinical Trial Phase: Phase 1 | Start Date: December 2007

Overall Status: Active, not recruiting

Estimated Enrollment: 24

Brief Summary

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”

Condition Keyword(s):

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

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

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.