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

Study Overview
=================
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.

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

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: rizatriptan benzoate (5 mg)
* Drug: rizatriptan benzoate (10 mg)
* Drug: Rizatriptan 5 mg Placebo
* Drug: Rizatriptan 10 mg Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel A Rizatriptan<br>Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. | Drug: rizatriptan benzoate (5 mg)<br>* A single dose of rizatriptan 5 mg administered on Day 1.<br>* Other names: MK0462;|
| Placebo Comparator: Panel A Placebo<br>Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. | Drug: Rizatriptan 5 mg Placebo<br>* A single dose of rizatriptan 5 mg placebo administered on Day 1.<br>|
| Experimental: Panel B Rizatriptan<br>Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. | Drug: rizatriptan benzoate (10 mg)<br>* A single dose of rizatriptan 10 mg administered on Day 1.<br>* Other names: MK0462;|
| Placebo Comparator: Panel B Placebo<br>Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. | Drug: Rizatriptan 10 mg Placebo<br>* A single dose of rizatriptan 10 mg placebo administered on Day 1.<br>|
| Experimental: Panel C Rizatriptan<br>Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. | Drug: rizatriptan benzoate (5 mg)<br>* A single dose of rizatriptan 5 mg administered on Day 1.<br>* Other names: MK0462;Drug: rizatriptan benzoate (10 mg)<br>* A single dose of rizatriptan 10 mg administered on Day 1.<br>* Other names: MK0462;|
| Placebo Comparator: Panel C Placebo<br>Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. | Drug: Rizatriptan 5 mg Placebo<br>* A single dose of rizatriptan 5 mg placebo administered on Day 1.<br>Drug: Rizatriptan 10 mg Placebo<br>* A single dose of rizatriptan 10 mg placebo administered on Day 1.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 24 Hours | 
| Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½) | Preliminary pharmacokinetics data; Apparent half-life (t½) | 24 Hours |