Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
NCT ID: NCT02191579
Last Updated: 2018-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
282 participants
INTERVENTIONAL
2014-08-05
2017-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
onabotulinumtoxinA
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
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®.
Topiramate
Topiramate up to a maximum oral dose of 100 mg/day.
Interventions
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onabotulinumtoxinA
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Topiramate
Topiramate up to a maximum oral dose of 100 mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Jo
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Neurology Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Robbins Headache Clinic
Riverwoods, Illinois, United States
International Clinical Research Institute Inc
Overland Park, Kansas, United States
Kansas City Bone and Joint Clinic
Overland Park, Kansas, United States
The NeuroMedical Center
Baton Rouge, Louisiana, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
New England Regional Headache Center Inc
Worcester, Massachusetts, United States
Allegiance Health
Jackson, Michigan, United States
Clinvest
Springfield, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Renown Institute for Neurosciences
Reno, Nevada, United States
Dent Neurosciences Research Center Incorporated
Amherst, New York, United States
Island Neurological Associates PC
Plainview, New York, United States
Montefiore Headache Center
The Bronx, New York, United States
Asheville Neurology Specialists PA
Asheville, North Carolina, United States
Headache Wellness Center
Greensboro, North Carolina, United States
Raleigh Neurology Associates PA
Raleigh, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
Main Line Health Lankenau Hospital
Wynnewood, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
Puget Sound Neurology
Tacoma, Washington, United States
Countries
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References
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Blumenfeld AM, Patel AT, Turner IM, Mullin KB, Manack Adams A, Rothrock JF. Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720959936. doi: 10.1177/2150132720959936.
Rothrock JF, Adams AM, Lipton RB, Silberstein SD, Jo E, Zhao X, Blumenfeld AM; FORWARD Study investigative group. FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. Headache. 2019 Nov;59(10):1700-1713. doi: 10.1111/head.13653. Epub 2019 Sep 26.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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FORWARD
Identifier Type: OTHER
Identifier Source: secondary_id
GMA-US-NEU-0206
Identifier Type: -
Identifier Source: org_study_id
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