Drug Study in Pediatric Subjects With Migraines - Full Text View

Sponsored by:	Merck
Information provided by:	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

Condition	Intervention	Phase
Migraine Disorders	Drug: rizatriptan benzoate Drug: Comparator : placebo (unspecified)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study
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

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To assess the safety and tolerability of single doses of MK0462 in pediatric migraineurs [ Time Frame: 5 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To obtain preliminary pharmacokinetic data following single dose administration of MK0462 [ Time Frame: 5 Weeks ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Panel A Panel A: study medication vs. Pbo	Drug: rizatriptan benzoate In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired. Drug: Comparator : placebo (unspecified) In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.
Panel B Panel B: study medication vs. Pbo	Drug: rizatriptan benzoate In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired. Drug: Comparator : placebo (unspecified) In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.

Arms

Assigned Interventions

Panel A

Panel A: study medication vs. Pbo

Drug: rizatriptan benzoate

In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.

Drug: Comparator : placebo (unspecified)

In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.

Panel B

Panel B: study medication vs. Pbo

Drug: rizatriptan benzoate

In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.

Drug: Comparator : placebo (unspecified)

In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.

Eligibility

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

Criteria

Inclusion Criteria:

Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
Patient 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604812

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results 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 & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_601, MK0462-083
Study First Received:	October 17, 2007
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00604812 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Benzoates
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Headache Disorders, Primary

Rizatriptan
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on July 02, 2009