Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

Completed · Phase 4

Conditions studied: Migraine Disorders

In brief

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

Key facts

Study ID

NCT02191579

Run by

Allergan

People needed

282

Starts

2014-08-05

Expected to finish

2017-09-01

Last updated by the study team

2018-06-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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