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

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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.


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
Saint Louis, Missouri 63141
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Amherst, NY
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Asheville, North Carolina 28806
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Baton Rouge, Louisiana 70810
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Bronx, New York 10461
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Dallas, Texas 75214
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Denver, Colorado 80210
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Denver, CO
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Doral, Florida 33172
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Doral, FL
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Encinitas, California 92024
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Encinitas, CA
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Fresno, California 93723
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Greensboro, North Carolina 27405
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Greensboro, NC
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Gulf Breeze, Florida 32561
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Gulf Breeze, FL
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
Allegiance Health Allegiance Health is a community-owned and locally-governed health system in Jackson, Michigan. We...
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Jackson, MI
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Newport Beach, California 92663
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Newport Beach, CA
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Overland Park, KS
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Overland Park, Kansas 66211
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15243
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Plainview, New York 11803
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Plainview, NY
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Raleigh, North Carolina 27607
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Raleigh, NC
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Reno, NV
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Riverwoods, Illinois 60015
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Sarasota, Florida 34239
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Springfield, Missouri 65807
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Stamford, CT
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Tacoma, Washington 98409
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Watertown, Massachusetts 02472
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Watertown, MA
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West Palm Beach, FL
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Worcester, Massachusetts 01605
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Wynnewood, Pennsylvania 19096
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