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

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: rizatriptan benzoate
  • In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.
• Drug: Comparator : placebo (unspecified)
  • In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.

Arms, Groups and Cohorts in this Clinical Trial

• Other: Panel A
  • Panel A: study medication vs. Pbo
• Other: Panel B
  • Panel B: study medication vs. Pbo

Primary Measures

• To assess the safety and tolerability of single doses of MK0462 in pediatric migraineurs
  • Time Frame: 5 Weeks
    Safety Issue?: Yes

Secondary Measures

• To obtain preliminary pharmacokinetic data following single dose administration of MK0462
  • Time Frame: 5 Weeks
    Safety Issue?: 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

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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

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