NCT00604812

Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	rizatriptan benzoate (5 mg)	A single dose of rizatriptan 5 mg administered on Day 1.
DRUG	rizatriptan benzoate (10 mg)	A single dose of rizatriptan 10 mg administered on Day 1.
DRUG	Rizatriptan 5 mg Placebo	A single dose of rizatriptan 5 mg placebo administered on Day 1.
DRUG	Rizatriptan 10 mg Placebo	A single dose of rizatriptan 10 mg placebo administered on Day 1.

Timeline

• Start date: 2007-12-17
• Primary completion: 2010-09-17
• Completion: 2010-09-17
• First posted: 2008-01-30
• Last updated: 2024-04-19
• Results posted: 2009-09-02