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

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 Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: rizatriptan benzoate (5 mg); Drug: Rizatriptan 5 mg Placebo; Drug: rizatriptan benzoate (10 mg); Drug: Rizatriptan 10 mg Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A Rizatriptan; 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); A single dose of rizatriptan 5 mg administered on Day 1.; Other Names: MK0462; MAXALT®
Placebo Comparator: Panel A Placebo; 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; A single dose of rizatriptan 5 mg placebo administered on Day 1.
Experimental: Panel B Rizatriptan; 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); A single dose of rizatriptan 10 mg administered on Day 1.; Other Names: MK0462; MAXALT®
Placebo Comparator: Panel B Placebo; 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; A single dose of rizatriptan 10 mg placebo administered on Day 1.
Experimental: Panel C Rizatriptan; 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); A single dose of rizatriptan 5 mg administered on Day 1.; Other Names: MK0462; MAXALT®; Drug: rizatriptan benzoate (10 mg); A single dose of rizatriptan 10 mg administered on Day 1.; Other Names: MK0462; MAXALT®
Placebo Comparator: Panel C Placebo; 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; 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.

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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2007
• Primary Completion (Actual): September 17, 2010
• Study Completion (Actual): September 17, 2010

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (Estimated): January 30, 2008

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Rizatriptan
• Other Study ID Numbers: 0462-083; 2007_601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php