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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604812
• Other study ID #: 0462-083
• Secondary ID: 2007_601
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2007
• Est. completion date: September 17, 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 17, 2010
• Est. primary completion date: September 17, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• rizatriptan benzoate (5 mg)
A single dose of rizatriptan 5 mg administered on Day 1.
• rizatriptan benzoate (10 mg)
A single dose of rizatriptan 10 mg administered on Day 1.
• Rizatriptan 5 mg Placebo
A single dose of rizatriptan 5 mg placebo administered on Day 1.
• Rizatriptan 10 mg Placebo
A single dose of rizatriptan 10 mg placebo administered on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs	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	Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-8))	Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-8)); i.e., area under the concentration-time plot	24 Hours
Secondary	Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)	Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved	24 Hours
Secondary	Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)	Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration	24 Hours
Secondary	Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)	Preliminary pharmacokinetics data; Apparent half-life (t½)	24 Hours