Migraine Clinical Trial
— MOTSOfficial title:
Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
Verified date | November 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 720 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver Headache Center | Aurora | Colorado |
United States | Brigham Women's Hospital Headache Clinic | Boston | Massachusetts |
United States | Brigham Women's Hospital Neurology Clinic | Boston | Massachusetts |
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 | University of Colorado Denver Primary Center | Denver | Colorado |
United States | Northern Arizona Healthcare Medical Group | Flagstaff | Arizona |
United States | Blue Sky Neurology | Greenwood Village | Colorado |
United States | Memorial Healthcare | Hollywood | Florida |
United States | Henry Ford Allegiance Health | Jackson | Michigan |
United States | Keck Medical Center of USC | Los Angeles | California |
United States | Norton Neurology | Louisville | Kentucky |
United States | University of Miami Miller School of Medicine | Miami | Florida |
United States | West Virginia University Neurology | Morgantown | West Virginia |
United States | Thomas Jefferson University Hospital Headache Center | Philadelphia | Pennsylvania |
United States | Mayo Clinic in Arizona Headache Center | Phoenix | Arizona |
United States | Mayo Clinic in Arizona Neurology Center | Phoenix | Arizona |
United States | Preferred Headache Center | Pittsburgh | Pennsylvania |
United States | The Headache Center | Ridgeland | Mississippi |
United States | Mayo Clinic Headache Center | Rochester | Minnesota |
United States | University of Utah General Neurology | Salt Lake City | Utah |
United States | University of Utah Headache Center | Salt Lake City | Utah |
United States | University of Utah Primary Care | Salt Lake City | Utah |
United States | Honor Health Neurology | Scottsdale | Arizona |
United States | Mayo Clinic Thunderbird | Scottsdale | Arizona |
United States | University of Washington | Seattle | Washington |
United States | Clinvest Research | Springfield | Missouri |
United States | Toledo Clinic Adult Neurology | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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