Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Status: | Completed |
---|---|
Conditions: | Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 6/9/2018 |
Start Date: | August 5, 2014 |
End Date: | September 1, 2017 |
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
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative)
treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic
migraine.
treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic
migraine.
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.
We found this trial at
32
sites
Stamford, Connecticut 06905
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Allegiance Health Allegiance Health is a community-owned and locally-governed health system in Jackson, Michigan. We...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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