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

NCT00604812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-04-19

Study results available
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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

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.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-17
Primary Completion
2010-09-17
Completion
2010-09-17

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00604812 on ClinicalTrials.gov