Conditions: Migraine Disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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. arm 5: 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. arm 6: 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.

Interventions: intervention 1: rizatriptan benzoate (5 mg) intervention 2: rizatriptan benzoate (10 mg) intervention 3: Rizatriptan 5 mg Placebo intervention 4: Rizatriptan 10 mg Placebo
Intervention descriptions: intervention 1: A single dose of rizatriptan 5 mg administered on Day 1. intervention 2: A single dose of rizatriptan 10 mg administered on Day 1. intervention 3: A single dose of rizatriptan 5 mg placebo administered on Day 1. intervention 4: A single dose of rizatriptan 10 mg placebo administered on Day 1.

Protocol document: