MigraineMOTSNCT02764320
The MOTS (Medication Overuse Treatment Strategy) Trial
A study testing Migraine Prophylactic Therapy Only and Discontinuation of Overused Medication in people with Migraine, run by Mayo Clinic at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Migraine Prophylactic Therapy Only and Discontinuation of Overused Medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 29 sitesUnited States
- Study dates
- 9 Jan 2017to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of Colorado Denver Headache Center
Aurora, Colorado, 80045
Brigham Women's Hospital Headache Clinic
Boston, Massachusetts, 02130
Brigham Women's Hospital Neurology Clinic
Boston, Massachusetts, 02130
University of Cincinnati Neurology
Cincinnati, Ohio, 45417
Cleveland Clinic
Cleveland, Ohio, 44195
University of Cincinnati Headache Center
Dayton, Ohio, 45417
University of Colorado Denver Primary Center
Denver, Colorado, 80238
Northern Arizona Healthcare Medical Group
Flagstaff, Arizona, 86001
Blue Sky Neurology
Greenwood Village, Colorado, 80111
Memorial Healthcare
Hollywood, Florida, 33021
Henry Ford Allegiance Health
Jackson, Michigan, 49201
Keck Medical Center of USC
Los Angeles, California, 90033
Norton Neurology
Louisville, Kentucky, 40207
University of Miami Miller School of Medicine
Miami, Florida, 33136
West Virginia University Neurology
Morgantown, West Virginia, 26506
Thomas Jefferson University Hospital Headache Center
Philadelphia, Pennsylvania, 19107
Mayo Clinic in Arizona Headache Center
Phoenix, Arizona, 85054
Mayo Clinic in Arizona Neurology Center
Phoenix, Arizona, 85054
Preferred Headache Center
Pittsburgh, Pennsylvania, 15236
The Headache Center
Ridgeland, Mississippi, 39157
Mayo Clinic Headache Center
Rochester, Minnesota, 55905
University of Utah Primary Care
Salt Lake City, Utah, 84106
University of Utah General Neurology
Salt Lake City, Utah, 84108
University of Utah Headache Center
Salt Lake City, Utah, 84132
Honor Health Neurology
Scottsdale, Arizona, 85251
Mayo Clinic Thunderbird
Scottsdale, Arizona, 85260
University of Washington
Seattle, Washington, 98195
Clinvest Research
Springfield, Missouri, 65801
Toledo Clinic Adult Neurology
Toledo, Ohio, 43623
About this study
Official title: Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
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.
- Conditions
- Migraine
- Being tested
- Migraine Prophylactic Therapy Only, Discontinuation of Overused Medication
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migraine Prophylactic Therapy OnlyOther
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
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
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation | Active comparator | Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) Receives: 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) Receives: Other: Migraine Prophylactic Therapy Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start9 Jan 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Todd J. Schwedt, Mayo Clinic
- Investigators
- Todd J Schwedt, MD, Principal investigator, Mayo ClinicDavid W Dodick, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764320
- Sponsor's protocol ID
- 16-001036
- Other IDs
- PCORI
- Acronym
- MOTS
- Status last verified
- Nov 2021
- First submitted
- 4 May 2016
- Last updated
- 12 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38663902Schwedt 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.
PubMed 35169011
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
- ClinicalTrials.gov ID
- NCT02764320
- Acronym / sponsor ID
- MOTS / 16-001036
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 12 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuation | Active comparator | Other: Discontinuation of Overused MedicationMigraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) |
| Preventive Therapy Only | Active comparator | Other: Migraine Prophylactic Therapy OnlyMigraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Migraine Prophylactic Therapy OnlyStart of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s) | Other | Preventive Therapy Only |
| Discontinuation of Overused MedicationImmediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy | Other | Discontinuation |
Primary outcome
Frequency of Moderate to Severe Headache Days
Time frame: 12 weeks
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38663902Whitaker 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.
- Derived from this study: PubMed 35169011Schwedt 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd J Schwedt, MD principal investigator
Mayo Clinic
David W Dodick, MD principal investigator
Mayo Clinic
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Migraine Prophylactic Therapy Only and Discontinuation of Overused Medication in people with Migraine, run by Mayo Clinic at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Moderate to Severe Headache Days (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021; AzTrials last refreshed its copy on 1 Nov 2026.