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: May 12, 2009
Verified by: Merck, May 2009
Clinical Trial Phase: Phase 1 | Start Date: December 2007
Overall Status: Completed
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):
Intervention(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
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
Outcome Measures for this Clinical Trial
Primary Measures
- To assess the safety and tolerability of single doses of MK0462 in pediatric migraineurs
- Time Frame: 5 Weeks
Safety Issue?: Yes
- Time Frame: 5 Weeks
Secondary Measures
- To obtain preliminary pharmacokinetic data following single dose administration of MK0462
- Time Frame: 5 Weeks
Safety Issue?: No
- Time Frame: 5 Weeks
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
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
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
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
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