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
Overview
- Phase
- Phase 4
- Intervention
- onabotulinumtoxinA
- Conditions
- Migraine Disorders
- Sponsor
- Allergan
- Enrollment
- 282
- Locations
- 32
- Primary Endpoint
- Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of chronic migraine
- •More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
Exclusion Criteria
- •Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- •Previous treatment with botulinum toxin of any serotype for any reason
- •Previous treatment with topiramate
- •On a ketogenic diet (high in fat, low in carbohydrates)
- •History of acute myopia or increased intraocular pressure
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- •Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Arms & Interventions
BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
Intervention: onabotulinumtoxinA
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®.
Intervention: Topiramate
Outcomes
Primary Outcomes
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Time Frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
Secondary Outcomes
- Change From Baseline in the Frequency of Headache Days Per 28-day Period(Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32)
- Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days(Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32)
- Change From Baseline in Headache Impact Test (HIT-6) Total Score(Baseline (Day 1) to the last 28-day period ending with Week 30)