The MOTS (Medication Overuse Treatment Strategy) Trial

Study Overview
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Brief Summary
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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.

Official Title
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Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse

Conditions
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Migraine

Intervention / Treatment
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* Other: Migraine Prophylactic Therapy Only
* Other: Discontinuation of Overused Medication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Discontinuation<br>Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) | Other: Discontinuation of Overused Medication<br>* Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy<br>|
| Active Comparator: Preventive Therapy Only<br>Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) | Other: Migraine Prophylactic Therapy Only<br>* Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |