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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-001036
  • PCORI (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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