Drug Study in Pediatric Subjects With Migraines
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Disorders
Intervention: rizatriptan benzoate (Drug); Comparator : placebo (unspecified) (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed
drug in pediatric subjects with migraines
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: To assess the safety and tolerability of single doses of MK0462 in pediatric migraineurs
Secondary outcome: To obtain preliminary pharmacokinetic data following single dose administration of MK0462
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
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
Starting date: December 2007
Last updated: January 31, 2008
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