The MOTS (Medication Overuse Treatment Strategy) Trial

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Arizona Healthcare Medical Group, Flagstaff, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Migraine Prophylactic Therapy Only

Other

Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)

Discontinuation of Overused Medication

Other

Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: MOTS

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: May 6, 2016
Registry last updated: Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed