The MOTS (Medication Overuse Treatment Strategy) Trial

Completed · Not applicable

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02764320

Run by

Mayo Clinic

People needed

720

Starts

2017-01-09

Expected to finish

2021-03-31

Last updated by the study team

2021-11-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Northern Arizona Healthcare Medical Group — Flagstaff, Arizona, United States
• Mayo Clinic in Arizona Headache Center — Phoenix, Arizona, United States
• Mayo Clinic in Arizona Neurology Center — Phoenix, Arizona, United States
• Honor Health Neurology — Scottsdale, Arizona, United States
• Mayo Clinic Thunderbird — Scottsdale, Arizona, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• University of Colorado Denver Headache Center — Aurora, Colorado, United States
• University of Colorado Denver Primary Center — Denver, Colorado, United States
• Blue Sky Neurology — Greenwood Village, Colorado, United States
• Memorial Healthcare — Hollywood, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Norton Neurology — Louisville, Kentucky, United States
• Brigham Women's Hospital Headache Clinic — Boston, Massachusetts, United States
• Brigham Women's Hospital Neurology Clinic — Boston, Massachusetts, United States
• Henry Ford Allegiance Health — Jackson, Michigan, United States
• Mayo Clinic Headache Center — Rochester, Minnesota, United States
• The Headache Center — Ridgeland, Mississippi, United States
• Clinvest Research — Springfield, Missouri, United States
• University of Cincinnati Neurology — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Cincinnati Headache Center — Dayton, Ohio, United States
• Toledo Clinic Adult Neurology — Toledo, Ohio, United States
• Thomas Jefferson University Hospital Headache Center — Philadelphia, Pennsylvania, United States
• Preferred Headache Center — Pittsburgh, Pennsylvania, United States
• University of Utah Primary Care — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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