Clinical trial NCT02764320: The MOTS (Medication Overuse Treatment Strategy) Trial
Official title: Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-05-06
Enrollment: 720
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Frequency of Moderate to Severe Headache Days
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona Healthcare Medical Group
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona Headache Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona Neurology Center
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health Neurology
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Thunderbird
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Headache Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Denver Primary Center
state: Colorado
city: Greenwood Village
country: United States
facility: Blue Sky Neurology
state: Colorado
city: Hollywood
country: United States
facility: Memorial Healthcare
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Louisville
country: United States
facility: Norton Neurology
state: Kentucky
city: Boston
country: United States
facility: Brigham Women's Hospital Headache Clinic
state: Massachusetts
city: Boston
country: United States
facility: Brigham Women's Hospital Neurology Clinic
state: Massachusetts
city: Jackson
country: United States
facility: Henry Ford Allegiance Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Headache Center
state: Minnesota
city: Ridgeland
country: United States
facility: The Headache Center
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati Neurology
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: University of Cincinnati Headache Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Adult Neurology
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital Headache Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Headache Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Primary Care
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah General Neurology
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Headache Center
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Neurology
state: West Virginia
Study officials:
affiliation: Mayo Clinic
name: Todd J Schwedt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: David W Dodick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.