CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
rizatriptan benzoate (5 mg) +3 moredrug
Likely dose
rizatriptan benzoate (5 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00604812
NCT00604812Phase 1Completed
CompareCT.gov

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

Organon and Co·interventional·Posted Jan 30, 2008·Updated Apr 19, 2024

In Brief

A Phase 1 clinical trial evaluating rizatriptan benzoate (5 mg), rizatriptan benzoate (10 mg), and 2 other interventions for Migraine Disorders. Completed, enrolled 31 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartDec 17, 2007
Primary CompletionSep 17, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

rizatriptan benzoate (5 mg)drug

A single dose of rizatriptan 5 mg administered on Day 1.

rizatriptan benzoate (10 mg)drug

A single dose of rizatriptan 10 mg administered on Day 1.

Rizatriptan 5 mg Placebodrug

A single dose of rizatriptan 5 mg placebo administered on Day 1.

Rizatriptan 10 mg Placebodrug

A single dose of rizatriptan 10 mg placebo administered on Day 1.