NINDS CRC Chronic Migraine Treatment Trial

Last updated: January 20, 2012
Sponsor: Anne Lindblad
Overall Status: Completed

Phase

3

Condition

Migraine (Pediatric)

Migraine And Cluster Headaches

Migraine (Adult)

Treatment

N/A

Clinical Study ID

NCT00772031
08-CRC-01
HHSN265200523641C
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of chronic migraine for at least 6 months

  • Age ≥ 18 years and age of migraine onset 60 or younger

  • EKG performed in the last 12 months

Exclusion

Exclusion Criteria:

  • Prior neuro-imaging suggesting secondary structural causes of headache

  • Beck Depression Inventory FastScreen score of 13 or greater or other severepsychiatric disorder

  • Contraindication to or prior intolerance of topiramate or propranolol (no history ofsinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma,kidney stones)

  • History of kidney failure or nephrolithiasis

  • A female who is currently pregnant or lactating or planning to become pregnant in thenext year, or is of child-bearing potential and not practicing an acceptable form ofbirth control

  • Currently requires butalbital or opioid drugs for acute headache treatment 10 or moredays a month

  • Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mgof propranolol

  • Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 inthe AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin,amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker,cyproheptadine; and tizanidine) within the last two months or has received botulinumtoxin injection in the past 3 months

Study Design

Total Participants: 191
Study Start date:
October 01, 2008
Estimated Completion Date:
September 30, 2010

Study Description

Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate is becoming the standard treatment among headache specialists. Experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. No randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine.

The goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. In the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. Participants will be followed for six months.

Connect with a study center

  • Mayo Clinic 5777 E Mayo Blvd

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Paradigm Clinical, Inc. 1324 W. Prince Rd

    Tuscon, Arizona 85705
    United States

    Site Not Available

  • Dr. Stephen David Forner - 1405 Magnolia Avenue, Suite B

    Chico, California 95926
    United States

    Site Not Available

  • Shanti Clinical Trials, 1880 West Washington Street

    Colton, California 92324
    United States

    Site Not Available

  • NervPro Research, 15825 Laguna Canyon Road, Suite 202

    Irvine, California 92618
    United States

    Site Not Available

  • Mercy Medical Group- CHWMF 3000 Q Street, Neurology

    Sacramento, California 95816
    United States

    Site Not Available

  • Health Sciences America, LLC, 1515 N Federal Hwy, Suite 105

    Boca Raton, Florida 33432
    United States

    Site Not Available

  • Southeast Clinical Research, LLC, 304 NE 1st Street

    Chiefland, Florida 32626
    United States

    Site Not Available

  • Scientific Clinical Research, Inc 1065 NE 125th Street , Ste 417

    Miami, Florida 33161
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach 8 Mirror Lake Drive Suite A&B

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Neurologique Foundation, Inc. 6 Fairfield Blvd. Suite 11

    Ponte Vedra, Florida 32082
    United States

    Site Not Available

  • Neurology Clinical Research, Inc, 3540 North Pine Island Rd

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Dr. B. Abraham, P.C. 3020 Highway 124

    Snellville, Georgia 30039
    United States

    Site Not Available

  • Ft. Wayne Neurological Center 7956 W. Jefferson Blvd.

    Ft. Wayne, Indiana 46804
    United States

    Site Not Available

  • MidAmerica Neuroscience Research Foundation, 8550 Marshall Dr, Suite 100

    Lenexa, Kansas 66214
    United States

    Site Not Available

  • Trover Health System Center for Clinical Studies, 200 Clinic Drive

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • New England Center for Clinical Research (NECCR), 52 Brigham St #7

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • New England Regional Headache Center, Inc 85 Prescott St, Ste 101

    Worcester, Massachusetts 01605-2982
    United States

    Site Not Available

  • ClinSite, LLC 24 Frank Lloyd Wright Drive, Lobby M

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Anderson & Collins Clinical Research 1 Ethel Road, Suite 106B

    Edison, New Jersey 08817
    United States

    Site Not Available

  • Dent Neurologic Institute, 3980 Sheridan Drive

    Amherst, New York 14226
    United States

    Site Not Available

  • Montefiore Headache Center 1575 Blondell Avenue Ste 225

    Bronx, New York 10461
    United States

    Site Not Available

  • Island Neurological Associates, PC, 824 Old Country Road

    Plainview, New York 11803
    United States

    Site Not Available

  • Schenectady Neurological Consultants 1401 Union Street

    Schenectady, New York 12308
    United States

    Site Not Available

  • Mission Neurology, Research Institute Mission Hospital, 509 Biltmore

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Guilford Neurologic Associates, 1126 North Church Street, Suite 200

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • ClinExcel Research 7908 Cincinnati-Dayton Rd, Ste J

    West Chester, Ohio 45069
    United States

    Site Not Available

  • Abington Neurological Associates, Ltd., 1245 Highland Avenue, Ste 301

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Neurology and Sleep Medicine PC, 701 Ostrum Street, Suite 302

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Jefferson Headache Center/Thomas Jefferson Univ. 111 South 11th Street, Suite 8130

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Progress Clinical Trials, 707 Kings Lane

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Texas Neurology, PA, 6301 Gaston Avenue, Suite 400 West Tower

    Dallas, Texas 75214
    United States

    Site Not Available

  • Houston Headache Clinic, 1213 Hermann Drive, Suite 820

    Houston, Texas 77004
    United States

    Site Not Available

  • Houston Sleep Center, Todd J. Swick, MD, PA, 7500 San Felipe, Suite 525

    Houston, Texas 77063
    United States

    Site Not Available

  • Protenium Clinical Research, LLC 1725 Chadwick Court Suite 200

    Hurst, Texas 76054
    United States

    Site Not Available

  • Starlight Clinical Research, 1325 W. South Jordan Pkwy, Ste 101

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Swedish Pain & Headache Center 101 Madison St, Suite 200

    Seattle, Washington 98116
    United States

    Site Not Available

  • West Virginia University 1 Medical Center Dr, Box 9180

    Morgantown, West Virginia 26506 - 9180
    United States

    Site Not Available

  • Gundersen Clinic, Ltd, 1836 South Avenue, MS: EB3-002

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

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