At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 674 enrolled
Drug / intervention
rizatriptan benzoatedrug
Likely dose
rizatriptan benzoate 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura
In Brief
A Phase 3 clinical trial evaluating rizatriptan benzoate for Acute Migraine With or Without Aura in Adolescents. Completed, enrolled 674 participants.
Detailed Summary
To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartDec 2009
Primary CompletionApr 2011
TodayJul 2026
First PostedOct 29, 2009
Enrollment StartDec 1, 2009
Primary CompletionApr 18, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.7 years ago
Interventions
rizatriptan benzoatedrug
Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack