The MOTS (Medication Overuse Treatment Strategy) Trial

Mayo Clinic

Status: Completed

Conditions: Migraine

Treatments: Other: Migraine Prophylactic Therapy Only; Other: Discontinuation of Overused Medication

Study type: Interventional

Funder types: Other

Identifiers

NCT02764320

PCORI (Other Grant/Funding Number)

16-001036

Details and patient eligibility

About

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.

Enrollment: 720 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

Discontinuation

Active Comparator group

Description:

Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)

Treatment:

Other: Discontinuation of Overused Medication

Preventive Therapy Only

Active Comparator group

Description:

Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)

Treatment:

Other: Migraine Prophylactic Therapy Only