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

Study Identifier
GMA-US-NEU-0206
CT.gov Identifier
NCT02191579
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Study Details

Medical Condition
  • Migraine - General
    • Study Drug
  • onabotulinumtoxinA
  • Topiramate
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    St Joseph's Hospital Barrow Neurology Clinics
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    North County Neurology Associates
    Encinitas, California, United States, 92024
    Status
    Not applicable
    Location
    California Headache and Balance Center
    Fresno, California, United States, 93723
    Status
    Not applicable
    Location
    Newport Beach Clinical Research Associates, Inc.
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Denver Neurological Clinic
    Denver, Colorado, United States, 80210
    Status
    Not applicable
    Location
    Ki Health Partners LLC DBA New England Institute for Neurology and Headache
    Stamford, Connecticut, United States, 06905
    Status
    Not applicable
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