At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 282 enrolled
Drug / intervention
onabotulinumtoxinA +1 morebiological
Likely dose
Topiramate 100 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 Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine
In Brief
A Phase 4 clinical trial evaluating onabotulinumtoxinA and Topiramate for Migraine Disorders. Completed, enrolled 282 participants across 32 sites.
Detailed Summary
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartAug 2014
Primary CompletionMay 2017
Study CompletionSep 2017
TodayJul 2026
First PostedJul 16, 2014
Enrollment StartAug 5, 2014
Primary CompletionMay 9, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.0 years ago
Interventions
onabotulinumtoxinAbiological
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Topiramatedrug
Topiramate up to a maximum oral dose of 100 mg/day.