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

Organon and Co31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine Disorders

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines * Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines * Subject 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

Outcomes

Primary Outcomes

Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs

All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)

Time frame: 24 Hours

Secondary Outcomes

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))

Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot

Time frame: 24 Hours

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)

Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved

Time frame: 24 Hours

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)

Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration

Time frame: 24 Hours

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)

Preliminary pharmacokinetics data; Apparent half-life (t½)

Time frame: 24 Hours

Data from ClinicalTrials.gov

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