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

Last updated: August 3, 2017
Sponsor: Allergan
Overall Status: Completed

Phase

3

Condition

Pain

Chronic Pain

Migraine (Adult)

Treatment

N/A

Clinical Study ID

NCT01662492
191622-103
  • Ages 12-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medical history of chronic migraine for at least 6 months

  • 15 or more headache days during a 4 week period

Exclusion

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 weeksprior to the week -4 screening visit

  • Use of any headache prophylaxis medication within 4 weeks prior to the week -4screening visit

Study Design

Total Participants: 125
Study Start date:
October 01, 2012
Estimated Completion Date:
August 31, 2016

Connect with a study center

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Fullerton Neurology and Headache Center

    Fullerton, California 92835
    United States

    Site Not Available

  • The Research Center of Southern California

    Oceanside, California 92056
    United States

    Site Not Available

  • San Francisco Clinical Research Center

    San Francisco, California 94109
    United States

    Site Not Available

  • Stanford Hospital and Clinics

    Stanford, California 94305
    United States

    Site Not Available

  • Associated Neurologists of Southern CT, P.C.

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida 32561
    United States

    Site Not Available

  • Pediatric Neurology, PA

    Orlando, Florida 32819
    United States

    Site Not Available

  • CORE (Center for Outpatient Research)

    Tampa, Florida 33606
    United States

    Site Not Available

  • The Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Advanced Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Josephson Wallack Munshower Neurology, P.C.

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • CPFCC Neurology Research Department

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • CORE (Center for Outpatient Research)

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Renown Institution for Neurosciences

    Reno, Nevada 89502
    United States

    Site Not Available

  • Clinical Research Center of NJ

    Vorhees, New Jersey 08043
    United States

    Site Not Available

  • Rochester Clinical Research, Inc

    Rochester, New York 14609
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Jill Waldo, CCRC

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Baptist Memorial Hospital-Memphis

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Nashville Neuroscience Group

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Association of Pediatric Neurology/Road Runner Research

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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