Thinking of joining a study?

Register your interest

Become a volunteer?

NCT02764320 | COMPLETED | Migraine

The MOTS (Medication Overuse Treatment Strategy) Trial
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Todd J. Schwedt

Brief Summary:

There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.

Condition or disease

Migraine

Intervention/treatment

Migraine Prophylactic Therapy Only

Discontinuation of Overused Medication

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 720 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
Actual Study Start Date : 2017-01-09
Estimated Primary Completion Date : 2021-03-31
Estimated Study Completion Date : 2021-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adults, at least 21 years of age
  • * Chronic Migraine - diagnosed according to ICHD3beta criteria
  • * Medication Overuse - diagnosed according to ICHD3beta criteria
  • * Willingness to be randomized to either of the two treatment arms
  • * Willingness to maintain a headache diary
  • * Plan for follow-up care with the clinician
  • * No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.
    • Exclusion Criteria
  • * Younger than 21 years of age
  • * Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
  • * Not willing to be randomized to either of the treatment arms
  • * Not willing to maintain a daily headache diary
  • * Not planning on follow-up care with the clinician
  • * In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
  • * Prisoners
  • * Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
    • The MOTS (Medication Overuse Treatment Strategy) Trial

    Location Details

    NCT02764320

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Arizona

    Northern Arizona Healthcare Medical Group

    Flagstaff, Arizona, United States, 86001

    Not yet recruiting

    United States, Arizona

    Mayo Clinic in Arizona Headache Center

    Phoenix, Arizona, United States, 85054

    Not yet recruiting

    United States, Arizona

    Mayo Clinic in Arizona Neurology Center

    Phoenix, Arizona, United States, 85054

    Not yet recruiting

    United States, Arizona

    Honor Health Neurology

    Scottsdale, Arizona, United States, 85251

    Not yet recruiting

    United States, Arizona

    Mayo Clinic Thunderbird

    Scottsdale, Arizona, United States, 85260

    Not yet recruiting

    United States, California

    Keck Medical Center of USC

    Los Angeles, California, United States, 90033

    Not yet recruiting

    United States, Colorado

    University of Colorado Denver Headache Center

    Aurora, Colorado, United States, 80045

    Not yet recruiting

    United States, Colorado

    University of Colorado Denver Primary Center

    Denver, Colorado, United States, 80238

    Not yet recruiting

    United States, Colorado

    Blue Sky Neurology

    Greenwood Village, Colorado, United States, 80111

    Not yet recruiting

    United States, Florida

    Memorial Healthcare

    Hollywood, Florida, United States, 33021

    Not yet recruiting

    United States, Florida

    University of Miami Miller School of Medicine

    Miami, Florida, United States, 33136

    Not yet recruiting

    United States, Kentucky

    Norton Neurology

    Louisville, Kentucky, United States, 40207

    Not yet recruiting

    United States, Massachusetts

    Brigham Women's Hospital Headache Clinic

    Boston, Massachusetts, United States, 02130

    Not yet recruiting

    United States, Massachusetts

    Brigham Women's Hospital Neurology Clinic

    Boston, Massachusetts, United States, 02130

    Not yet recruiting

    United States, Road cancer

    Henry Ford Allegiance Health

    Jackson, Road cancer, United States, 49201

    Not yet recruiting

    United States, Minnesota

    Mayo Clinic Headache Center

    Rochester, Minnesota, United States, 55905

    Not yet recruiting

    United States, Mississippi

    The Headache Center

    Ridgeland, Mississippi, United States, 39157

    Not yet recruiting

    United States, Missouri

    Clinvest Research

    Springfield, Missouri, United States, 65801

    Not yet recruiting

    United States, Ohio

    University of Cincinnati Neurology

    Cincinnati, Ohio, United States, 45417

    Not yet recruiting

    United States, Ohio

    Cleveland Clinic

    Cleveland, Ohio, United States, 44195

    Not yet recruiting

    United States, Ohio

    University of Cincinnati Headache Center

    Dayton, Ohio, United States, 45417

    Not yet recruiting

    United States, Ohio

    Toledo Clinic Adult Neurology

    Toledo, Ohio, United States, 43623

    Not yet recruiting

    United States, Pennsylvania

    Thomas Jefferson University Hospital Headache Center

    Philadelphia, Pennsylvania, United States, 19107

    Not yet recruiting

    United States, Pennsylvania

    Preferred Headache Center

    Pittsburgh, Pennsylvania, United States, 15236

    Not yet recruiting

    United States, Utah

    University of Utah Primary Care

    Salt Lake City, Utah, United States, 84106

    Not yet recruiting

    United States, Utah

    University of Utah General Neurology

    Salt Lake City, Utah, United States, 84108

    Not yet recruiting

    United States, Utah

    University of Utah Headache Center

    Salt Lake City, Utah, United States, 84132

    Not yet recruiting

    United States, Washington

    University of Washington

    Seattle, Washington, United States, 98195

    Not yet recruiting

    United States, West Virginia

    West Virginia University Neurology

    Morgantown, West Virginia, United States, 26506