The MOTS (Medication Overuse Treatment Strategy) Trial (MOTS)

November 10, 2021 updated by: Todd J. Schwedt, Mayo Clinic

Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Northern Arizona Healthcare Medical Group
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona Headache Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona Neurology Center
      • Scottsdale, Arizona, United States, 85251
        • Honor Health Neurology
      • Scottsdale, Arizona, United States, 85260
        • Mayo Clinic Thunderbird
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver Headache Center
      • Denver, Colorado, United States, 80238
        • University of Colorado Denver Primary Center
      • Greenwood Village, Colorado, United States, 80111
        • Blue Sky Neurology
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Neurology
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Brigham Women's Hospital Headache Clinic
      • Boston, Massachusetts, United States, 02130
        • Brigham Women's Hospital Neurology Clinic
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Henry Ford Allegiance Health
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Headache Center
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • The Headache Center
    • Missouri
      • Springfield, Missouri, United States, 65801
        • Clinvest Research
    • Ohio
      • Cincinnati, Ohio, United States, 45417
        • University of Cincinnati Neurology
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Dayton, Ohio, United States, 45417
        • University of Cincinnati Headache Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Adult Neurology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital Headache Center
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Headache Center
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • University of Utah Primary Care
      • Salt Lake City, Utah, United States, 84108
        • University of Utah General Neurology
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Headache Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Discontinuation
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Other: Discontinuation of Overused Medication
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy
Active Comparator: Preventive Therapy Only
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Other: Migraine Prophylactic Therapy Only
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Moderate to Severe Headache Days
Time Frame: 12 weeks
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Todd J Schwedt, MD, Mayo Clinic
  • Principal Investigator: David W Dodick, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001036
  • PCORI (Other Grant/Funding Number: AD-1304-6650)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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