DOI: 10.3886/icpsr38546.v1
title: Comparing Two Ways to Manage Symptoms for Patients Who Have Chronic Migraine and Frequent Medication Use (The MOTS Trial), United States, 2017-2020
title: Version 1

description: The Medication Overuse Treatment Strategy (MOTS) research trial sought to understand the relationship between individuals who suffer from chronic migraines and their use (or overuse) of medications to treat their migraines. A diagnosis of chronic migraines means that a person experiences headaches on 15 days or more per month with at least 8 of those days meeting the diagnostic criteria for migraine with or without aura. Of the nearly 7 million individuals in the United States who suffer from chronic migraines more than half of them overuse medication intended to relieve the symptoms. However, that overuse can bring about other medical issues. This research trial enrolled 720 chronic migraine sufferers from 34 clinics across the country. The subjects were randomized into two groups. A total of 361 patients were randomized to the treatment strategy that included migraine-preventive therapy with switching off the overused medication to an alternative used with a limited frequency, while 359 patients were randomized to migraine-preventive medication with continuation of the overused medication with no maximum limit.
description: The principal aim of this study was to compare two methods of treatment for individuals who suffer from chronic migraines who were also overusing medication for treatment. The goal was to see if continuing the overused medication was non-inferior to discontinuation of that medication and switching to a drug from another class.
description: This is a prospective, parallel group, simple randomized trial during which patients were randomized 1:1 to one of two treatment strategies: migraine prophylactic therapy <strong>WITH</strong> immediate discontinuation of the overused medication and switched to an alternative medication in a different class used less than or equal to 2 days per week migraine prophylactic therapy <strong>WITHOUT</strong> early discontinuation of the overused medication Each patient must have had a research visit at baseline / randomization, and then at 12 weeks post-randomization. These visits could be in-person or via telehealth (telephone, e-mail, video, or regular mail). Other follow-up visits occurred according to the clinician's usual follow-up patterns (clinical visits, not study specified visits).
description: The Principal Investigator prepared the datasets by topic. A brief description of each file follows below. <strong>DS1 Inclusion / Exlcusion Criteria:</strong> (14 vars / 978 cases) - did the subject agree to enroll in the study, and did the person meet the criteria outlined in the Sampling section <strong>DS2 Project Participation:</strong> (11 vars / 674 cases) - whether the respondent completed the study, or withdrew from it and the reasons for withdrawal <strong>DS3 Subject Demographics:</strong> (6 vars / 720 cases) - provides the respondent's age, gender, race, and ethnicity <strong>DS4 Medication Treatment:</strong> (16 vars / 4,597 cases) - name of medication or treatment, how it was taken and how much, and whether or not it was overused <strong>DS5 Medication Use / Overuse:</strong> (13 vars / 1,780 cases) - how long the respondent has overused the medication and what the overuse was attributed to <strong>DS6 Headache Characteristics: Baseline:</strong> (46 vars / 718 cases) - number of days and hours experienced headaches over the past 30 days, and the severity, location, and effects of the headaches <strong>DS7 Headache Characteristics: Follow-Up:</strong> (15 vars / 1,083 cases) - number of days over the past 30 having some type of headache, number of hours the headache lasted, a rating of the pain felt, and the number of days over the past 30 medication was used <strong>DS8 Pain Rating / Effects:</strong> (62 vars / 1,786 cases) - severity and interference of headaches in every day life, and difficulties / limitations over the past 7 days because of headaches <strong>DS9 Adverse Events:</strong> (20 vars / 234 cases) - whether or not an adverse event occurred, and what type of event it was <strong>DS10 Headache and Medication Daily Diary:</strong> (60 vars / 43,989 cases) - did the respondent have a headache that day, how long it lasted, and its' intensity, also opportunity to list up to 15 medications taken that day <strong>DS11 Project Analysis:</strong> (434 vars / 720 cases) - contains repeating questions and scores taken at baseline, 12 weeks, 24 weeks, and 48 weeks
description: None
description: Response Rates: A total of 978 patients were thought to be eligible for the study. Of those 720 were ultimately enrolled and randomized into the trial.
description: Presence of Common Scales: Generalized Anxiety Disorder 7 (GAD-7) Headache Impact Test 6 (HIT-6) PROMIS Pain Interference Patient Health Questionnaire 9 (PHQ-9) EuroQol 5D (EQ-5D-3L)
description: To be considered for inclusion into the study a patient had to meet the following criteria: Adults at least 21 years of age Diagnosed with chronic migraines as defined by ICHD3beta criteria Diagnosed with medication overuse defined by ICHD3beta criteria Willingness to be randomized into either of the 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 Consecutive patients presenting at the investigator's clinic, in-person or via telehealth, who met the inclusion criteria were offered enrollment into the study. Participants were not excluded based upon measures of clinical severity or based upon preconceived notions of likelihood to respond to study interventions. ICHD3beta Chronic Migraine Diagnostic Criteria A. Headache on 15 days or more per month for 3 or more months B. Occurring in a patient with 5 or more migraine attacks with or without aura C. On 8 days or more for more than 3 months D. Not better accounted for by another headache diagnosis ICHD3beta Medication Overuse Diagnostic Criteria A. Regular intake of ergotamine, triptans, opioids, combination analgesics, or a combination of drugs from different classes on 10 days or more per month for more than 3 months B. Regular intake of simple analgesics (e.g., aceteminophen, NSAIDS) on 15 days or more per month for more than 3 months
description: Datasets: DS0: Study-Level Files DS1: Inclusion / Exclusion Criteria DS2: Project Participation DS3: Subject Demographics DS4: Medication Treatment DS5: Medication Use / Overuse DS6: Headache Characteristics: Baseline DS7: Headache Characteristics: Follow-Up DS8: Pain Rating / Effects DS9: Adverse Events DS10: Headache and Medication Daily Diary DS11: Project Analysis
description: MOTS trial participants enrolled from 34 health care clinics, including 6 primary care clinics, 14 general neurology clinics, and 14 headache specialty clinics distributed across the United States. Smallest Geographic Unit: None
description: record abstractsEach of the 11 datasets begins with the respondent identification variable <strong>SUBJECT</strong>. This variable can be used to link the files together.