- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00604812
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
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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. |
A single dose of rizatriptan 5 mg administered on Day 1.
Other Names:
|
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. |
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. |
A single dose of rizatriptan 10 mg administered on Day 1.
Other Names:
|
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. |
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. |
A single dose of rizatriptan 5 mg administered on Day 1.
Other Names:
A single dose of rizatriptan 10 mg administered on Day 1.
Other Names:
|
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. |
A single dose of rizatriptan 5 mg placebo administered on Day 1.
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
Time Frame: 24 Hours
|
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-∞))
Time Frame: 24 Hours
|
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)
Time Frame: 24 Hours
|
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)
Time Frame: 24 Hours
|
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)
Time Frame: 24 Hours
|
Preliminary pharmacokinetics data; Apparent half-life (t½)
|
24 Hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0462-083
- 2007_601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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