Status:
COMPLETED
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Lead Sponsor:
Allergan
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT02191579
Start Date
August 5 2014
End Date
September 1 2017
Last Update
June 7 2018
Active Locations (32)
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1
St Joseph's Hospital Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
2
North County Neurology Associates
Encinitas, California, United States, 92024
3
California Headache and Balance Center
Fresno, California, United States, 93723
4
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States, 92663