Clinical trial

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

Name

0462-083

Description

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.

Trial arms

Trial start

2007-12-17

Estimated PCD

2010-09-17

Trial end

2010-09-17

Status

Completed

Phase

Early phase I

Treatment

rizatriptan benzoate (5 mg)

A single dose of rizatriptan 5 mg administered on Day 1.

Arms:

Panel A Rizatriptan, Panel C Rizatriptan

Other names:

MAXALT®, MK0462

rizatriptan benzoate (10 mg)

A single dose of rizatriptan 10 mg administered on Day 1.

Arms:

Panel B Rizatriptan, Panel C Rizatriptan

Other names:

MAXALT®, MK0462

Rizatriptan 5 mg Placebo

A single dose of rizatriptan 5 mg placebo administered on Day 1.

Arms:

Panel A Placebo, Panel C Placebo

Rizatriptan 10 mg Placebo

A single dose of rizatriptan 10 mg placebo administered on Day 1.

Arms:

Panel B Placebo, Panel C Placebo

Size

Primary endpoint

Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs

24 Hours

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

Updated at

2024-04-19

1 organization

2 products

1 indication

Organization

Product

Indication

Product