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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

720

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

First Submitted

Initial submission to the registry

May 4, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed

8 months until next milestone

Study Start

First participant enrolled

January 9, 2017

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed

8 months until next milestone

Results Posted

Study results publicly available

November 12, 2021

Completed

Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

May 4, 2016

Results QC Date

October 12, 2021

Last Update Submit

November 10, 2021

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

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
12 weeks

Study Arms (2)

Discontinuation

ACTIVE COMPARATOR

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

Other: Discontinuation of Overused Medication

Preventive Therapy Only

ACTIVE COMPARATOR

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

Other: Migraine Prophylactic Therapy Only

Interventions

Migraine Prophylactic Therapy OnlyOTHER

Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)

Preventive Therapy Only

Discontinuation of Overused MedicationOTHER

Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy

Discontinuation

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Mayo Cliniclead
Patient-Centered Outcomes Research Institutecollaborator

Study Sites (29)

Northern Arizona Healthcare Medical Group

Flagstaff, Arizona, 86001, United States

Location

Mayo Clinic in Arizona Headache Center

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona Neurology Center

Phoenix, Arizona, 85054, United States

Location

Honor Health Neurology

Scottsdale, Arizona, 85251, United States

Location

Mayo Clinic Thunderbird

Scottsdale, Arizona, 85260, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

University of Colorado Denver Headache Center

Aurora, Colorado, 80045, United States

Location

University of Colorado Denver Primary Center

Denver, Colorado, 80238, United States

Location

Blue Sky Neurology

Greenwood Village, Colorado, 80111, United States

Location

Memorial Healthcare

Hollywood, Florida, 33021, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Norton Neurology

Louisville, Kentucky, 40207, United States

Location

Brigham Women's Hospital Headache Clinic

Boston, Massachusetts, 02130, United States

Location

Brigham Women's Hospital Neurology Clinic

Boston, Massachusetts, 02130, United States

Location

Henry Ford Allegiance Health

Jackson, Michigan, 49201, United States

Location

Mayo Clinic Headache Center

Rochester, Minnesota, 55905, United States

Location

The Headache Center

Ridgeland, Mississippi, 39157, United States

Location

Clinvest Research

Springfield, Missouri, 65801, United States

Location

University of Cincinnati Neurology

Cincinnati, Ohio, 45417, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Cincinnati Headache Center

Dayton, Ohio, 45417, United States

Location

Toledo Clinic Adult Neurology

Toledo, Ohio, 43623, United States

Location

Thomas Jefferson University Hospital Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Preferred Headache Center

Pittsburgh, Pennsylvania, 15236, United States

Location

University of Utah Primary Care

Salt Lake City, Utah, 84106, United States

Location

University of Utah General Neurology

Salt Lake City, Utah, 84108, United States

Location

University of Utah Headache Center

Salt Lake City, Utah, 84132, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

West Virginia University Neurology

Morgantown, West Virginia, 26506, United States

Location

Related Publications (2)

Whitaker DJ, Dumkrieger GM, Hentz JG, Dodick DW, Schwedt TJ. Physical impairment during and between migraine attacks: A daily diary study of patients with chronic migraine. Cephalalgia. 2024 Apr;44(4):3331024241249747. doi: 10.1177/03331024241249747.
PMID: 38663902DERIVED
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.
PMID: 35169011DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title: Dr. Todd J. Schwedt
Organization: Mayo Clinic

Study Officials

Todd J Schwedt, MD
Mayo Clinic
PRINCIPAL INVESTIGATOR
David W Dodick, MD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PI

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

January 9, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

November 12, 2021

Results First Posted

November 12, 2021

Record last verified: 2021-11

Locations

US(29)

The MOTS (Medication Overuse Treatment Strategy) Trial

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Discontinuation

Preventive Therapy Only

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Discontinuation

Preventive Therapy Only

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations