Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
|ClinicalTrials.gov Identifier: NCT02191579|
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Biological: onabotulinumtoxinA Drug: Topiramate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||August 5, 2014|
|Actual Primary Completion Date :||May 9, 2017|
|Actual Study Completion Date :||September 1, 2017|
Active Comparator: BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Active Comparator: Topiramate
Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.
Topiramate up to a maximum oral dose of 100 mg/day.
Other Name: Topamax®
- Percentage of Participants with a ≥ 50% Decrease from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 32 ]
- Frequency of Headache Days [ Time Frame: 32 Weeks ]
- Headache Impact Test (HIT-6) Total Score [ Time Frame: Week 32 ]
- Percentage of Participants with a ≥ 70% Decrease from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 32 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191579
Show 35 Study Locations
|Study Director:||Esther Jo||Allergan|