clinical trial · NCT00604812
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Organon and Co·phase1·completed·n = 31
Migraine Disordersrizatriptan benzoate (5 mg)rizatriptan benzoate (10 mg)Rizatriptan 5 mg PlaceboRizatriptan 10 mg Placebo
brief summary
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines. After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.
started
Dec 17, 2007
primary completion
Sep 17, 2010
completion
Sep 17, 2010
last updated
Apr 19, 2024
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol