Drug Study in Pediatric Subjects With Migraines - Tabular View

Tracking Information

First Received Date ^ICMJE

October 17, 2007

Last Updated Date

September 2, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00604812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Drug Study in Pediatric Subjects With Migraines

Official Title ^ICMJE

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

Brief Summary

A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Migraine Disorders

Intervention ^ICMJE

Drug: rizatriptan benzoate (5 mg)
Drug: rizatriptan benzoate (10 mg)
Drug: Comparator: Placebo

Study Arms / Comparison Groups

Experimental: Rizatriptan 5 mg
Placebo Comparator: placebo
Experimental: Rizatriptan 10 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00604812

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_601, MK0462-083

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP