Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
- Conditions
- Migraine Disorders
- Interventions
- Biological: onabotulinumtoxinA
- Registration Number
- NCT02191579
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BOTOX® onabotulinumtoxinA 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. Topiramate 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®.
- Primary Outcome Measures
Name Time Method Percentage of Participants With a ≥ 50% 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 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 Outcome Measures
Name Time Method 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 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. A negative change from Baseline (less headache days) indicates improvement.
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 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 ≥ 70% 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.
Change From Baseline in Headache Impact Test (HIT-6) Total Score Baseline (Day 1) to the last 28-day period ending with Week 30 The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a "best to worst" scoring.
A negative change from Baseline (a lower score) indicates improvement.
Trial Locations
- Locations (32)
St Joseph's Hospital Barrow Neurology Clinics
🇺🇸Phoenix, Arizona, United States
North County Neurology Associates
🇺🇸Encinitas, California, United States
California Headache and Balance Center
🇺🇸Fresno, California, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Denver Neurological Clinic
🇺🇸Denver, Colorado, United States
Ki Health Partners LLC DBA New England Institute for Neurology and Headache
🇺🇸Stamford, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
🇺🇸Boca Raton, Florida, United States
Design Neuroscience Center
🇺🇸Doral, Florida, United States
NW FL Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
Negroski, Sutherland & Hanes Neurology
🇺🇸Sarasota, Florida, United States
Scroll for more (22 remaining)St Joseph's Hospital Barrow Neurology Clinics🇺🇸Phoenix, Arizona, United States