Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Disorders
Intervention: rizatriptan benzoate (5 mg) (Drug); rizatriptan benzoate (10 mg) (Drug); Rizatriptan 5 mg Placebo (Drug); Rizatriptan 10 mg Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
Secondary outcome: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax) Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax) Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Starting date: December 2007
Last updated: November 24, 2014
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