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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Migraine Prophylactic Therapy Only
Discontinuation of Overused Medication
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northern Arizona Healthcare Medical Group
  • Mayo Clinic in Arizona Headache Center
  • Mayo Clinic in Arizona Neurology Center
  • Honor Health Neurology
  • Mayo Clinic Thunderbird
  • Keck Medical Center of USC
  • University of Colorado Denver Headache Center
  • University of Colorado Denver Primary Center
  • Blue Sky Neurology
  • Memorial Healthcare
  • University of Miami Miller School of Medicine
  • Norton Neurology
  • Brigham Women's Hospital Headache Clinic
  • Brigham Women's Hospital Neurology Clinic
  • Henry Ford Allegiance Health
  • Mayo Clinic Headache Center
  • The Headache Center
  • Clinvest Research
  • University of Cincinnati Neurology
  • Cleveland Clinic
  • University of Cincinnati Headache Center
  • Toledo Clinic Adult Neurology
  • Thomas Jefferson University Hospital Headache Center
  • Preferred Headache Center
  • University of Utah Primary Care
  • University of Utah General Neurology
  • University of Utah Headache Center
  • University of Washington
  • West Virginia University Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Discontinuation

Preventive Therapy Only

Arm Description

Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)

Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)

Outcomes

Primary Outcome Measures

Frequency of Moderate to Severe Headache Days
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity

Secondary Outcome Measures

Full Information

First Posted
May 4, 2016
Last Updated
November 10, 2021
Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02764320
Brief Title
The MOTS (Medication Overuse Treatment Strategy) Trial
Acronym
MOTS
Official Title
Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Discontinuation
Arm Type
Active Comparator
Arm Description
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Arm Title
Preventive Therapy Only
Arm Type
Active Comparator
Arm Description
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Intervention Type
Other
Intervention Name(s)
Migraine Prophylactic Therapy Only
Intervention Description
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Intervention Type
Other
Intervention Name(s)
Discontinuation of Overused Medication
Intervention Description
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy
Primary Outcome Measure Information:
Title
Frequency of Moderate to Severe Headache Days
Description
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd J Schwedt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David W Dodick, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Arizona Healthcare Medical Group
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Mayo Clinic in Arizona Headache Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic in Arizona Neurology Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Honor Health Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Mayo Clinic Thunderbird
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado Denver Headache Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Denver Primary Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80238
Country
United States
Facility Name
Blue Sky Neurology
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Memorial Healthcare
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Norton Neurology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Brigham Women's Hospital Headache Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Brigham Women's Hospital Neurology Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Henry Ford Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Mayo Clinic Headache Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Headache Center
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Clinvest Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65801
Country
United States
Facility Name
University of Cincinnati Neurology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Cincinnati Headache Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Toledo Clinic Adult Neurology
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Thomas Jefferson University Hospital Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Preferred Headache Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
University of Utah Primary Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Utah General Neurology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Utah Headache Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University Neurology
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35169011
Citation
Schwedt TJ, Hentz JG, Sahai-Srivastava S, Murinova N, Spare NM, Treppendahl C, Martin VT, Birlea M, Digre K, Watson D, Leonard M, Robert T, Dodick DW; MOTS Investigators. Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial. Neurology. 2022 Apr 5;98(14):e1409-e1421. doi: 10.1212/WNL.0000000000200117. Epub 2022 Feb 15.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

The MOTS (Medication Overuse Treatment Strategy) Trial

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