A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

Study Identifier
191622-103
CT.gov Identifier
NCT01662492
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
  • Botulinum toxin type A Dose 1
  • Botulinum toxin type A Dose 2
  • Placebo (Normal Saline)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Medical history of chronic migraine for at least 6 months * 15 or more headache days during a 4 week period
    Exclusion Criteria:
    * Previous use of any botulinum toxin of any serotype for any reason * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit * Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

    Protocol Summary

    To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

    Study Locations

    Location
    Status
    Location
    Phoenix Children's Hospital
    Phoenix, Arizona, United States, 85016
    Status
    Not applicable
    Location
    Fullerton Neurology and Headache Center
    Fullerton, California, United States, 92835
    Status
    Not applicable
    Location
    The Research Center of Southern California
    Oceanside, California, United States, 92056
    Status
    Not applicable
    Location
    San Francisco Clinical Research Center
    San Francisco, California, United States, 94109
    Status
    Not applicable
    Location
    Stanford Hospital and Clinics
    Stanford, California, United States, 94305
    Status
    Not applicable
    Location
    Associated Neurologists of Southern CT, P.C.
    Fairfield, Connecticut, United States, 06824
    Status
    Not applicable
    Showing {first} - {last} of {total} Results