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

Oral Facial Pain

Pain (Pediatric)

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

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.