A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

Study Identifier
GMA-BTX-CM-10-001
CT.gov Identifier
NCT01516892
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Migraine - General
    • Study Drug
  • onabotulinumtoxinA
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
    Exclusion Criteria:
    * Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis * Headache attributed to another disorder * Infection or skin disorder at injection sites * Previous treatment with botulinum toxin of any serotype for any reason * Anticipated need for botulinum toxin of any type for any reason during the course of the study * Previous participation in any botulinum toxin clinical trial

    Protocol Summary

    This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

    Study Locations

    Location
    Status
    Location
    Arizona Neurological Institute
    Scottsdale, Arizona, United States, 85255-7450
    Status
    Not applicable
    Location
    The Research Center of Southern California, LLC
    Encinitas, California, United States, 92024
    Status
    Not applicable
    Location
    USC Neurology
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    UCSF Headache Center
    San Francisco, California, United States, 94133
    Status
    Not applicable
    Location
    Neurological Research Institute
    Santa Monica, California, United States, 90404
    Status
    Not applicable
    Location
    Advanced Neurosciences Research, LLC
    Fort Collins, Colorado, United States, 80528
    Status
    Not applicable
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