At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents
In Brief
A Phase 3 clinical trial evaluating rizatriptan and placebo for Migraine, Acute. Completed, enrolled 1,382 participants.
Detailed Summary
This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.
Study Details
Timeline
Interventions
For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.
For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.
For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder \[moderate or severe pain 15 minutes after dose\] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.
For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.