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

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00604812

Purpose

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.

Condition	Intervention	Phase
Migraine Disorders	Drug: rizatriptan benzoate (5 mg) Drug: rizatriptan benzoate (10 mg) Drug: Rizatriptan 5 mg Placebo Drug: Rizatriptan 10 mg Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate Potassium benzoate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs [ Time Frame: 24 Hours ] [ Designated as safety issue: Yes ]
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)

Secondary Outcome Measures:

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Preliminary pharmacokinetics data; Apparent half-life (t½)

Enrollment:	31
Study Start Date:	December 2007
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: MAXALT® MK0462
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: MAXALT® MK0462
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: MAXALT® MK0462 Drug: rizatriptan benzoate (10 mg) A single dose of rizatriptan 10 mg administered on Day 1. Other Names: MAXALT® MK0462
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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00604812 History of Changes
Other Study ID Numbers:	MK-0462-083, 2007_601
Study First Received:	October 17, 2007
Results First Received:	June 3, 2009
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Benzoates
Rizatriptan
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012