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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00604812

First received: October 17, 2007

Last updated: September 16, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 17, 2007
Last Updated Date	September 16, 2011
Start Date ^ICMJE	December 2007
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 20, 2010)	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)
Original Primary Outcome Measures ^ICMJE (submitted: January 17, 2008)	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 (submitted: April 20, 2010)	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)
Original Secondary Outcome Measures ^ICMJE (submitted: January 17, 2008)	To obtain preliminary pharmacokinetic data following single dose administration of MK0462 [ Time Frame: 5 Weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Migraine Disorders
Intervention ^ICMJE	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 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.
Study Arm (s)	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. Intervention: Drug: rizatriptan benzoate (5 mg) 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. Intervention: Drug: Rizatriptan 5 mg Placebo 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. Intervention: Drug: rizatriptan benzoate (10 mg) 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. Intervention: Drug: Rizatriptan 10 mg Placebo 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. Interventions: Drug: rizatriptan benzoate (5 mg) Drug: rizatriptan benzoate (10 mg) 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. Interventions: Drug: Rizatriptan 5 mg Placebo Drug: Rizatriptan 10 mg Placebo
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	6 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00604812
Other Study ID Numbers ^ICMJE	MK-0462-083, 2007_601
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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