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

Organon

Status and phase: Completed; Phase 1

Conditions: Migraine Disorders

Treatments: Drug: rizatriptan benzoate (10 mg); Drug: Rizatriptan 5 mg Placebo; Drug: rizatriptan benzoate (5 mg); Drug: Rizatriptan 10 mg Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00604812

2007_601

0462-083

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 6 patient groups, including a placebo group

Panel A Rizatriptan

Experimental group

Description:

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.

Treatment:

Drug: rizatriptan benzoate (5 mg)

Panel A Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Rizatriptan 5 mg Placebo

Panel B Rizatriptan

Experimental group

Description:

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.

Treatment:

Drug: rizatriptan benzoate (10 mg)

Panel B Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Rizatriptan 10 mg Placebo

Panel C Rizatriptan

Experimental group

Description:

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.

Treatment:

Drug: rizatriptan benzoate (5 mg)

Drug: rizatriptan benzoate (10 mg)

Panel C Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Rizatriptan 5 mg Placebo

Drug: Rizatriptan 10 mg Placebo