Comparing Two Ways to Manage Symptoms for Patients Who Have Chronic Migraine and Frequent Medication Use (The MOTS Trial), United States, 2017-2020 (ICPSR 38546)

Time Period(s) View help for Time Period(s)

Date of Collection View help for Date of Collection

Data Collection Notes View help for Data Collection Notes

Study Purpose View help for Study Purpose

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.

Study Design View help for Study Design

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 WITH 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 WITHOUT 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).

Sample View help for Sample

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

Time Method View help for Time Method

Universe View help for Universe

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.

Unit(s) of Observation View help for Unit(s) of Observation

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

Description of Variables View help for Description of Variables

The Principal Investigator prepared the datasets by topic. A brief description of each file follows below.

• DS1 Inclusion / Exlcusion Criteria: (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
• DS2 Project Participation: (11 vars / 674 cases) - whether the respondent completed the study, or withdrew from it and the reasons for withdrawal
• DS3 Subject Demographics: (6 vars / 720 cases) - provides the respondent's age, gender, race, and ethnicity
• DS4 Medication Treatment: (16 vars / 4,597 cases) - name of medication or treatment, how it was taken and how much, and whether or not it was overused
• DS5 Medication Use / Overuse: (13 vars / 1,780 cases) - how long the respondent has overused the medication and what the overuse was attributed to
• DS6 Headache Characteristics: Baseline: (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
• DS7 Headache Characteristics: Follow-Up: (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
• DS8 Pain Rating / Effects: (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
• DS9 Adverse Events: (20 vars / 234 cases) - whether or not an adverse event occurred, and what type of event it was
• DS10 Headache and Medication Daily Diary: (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
• DS11 Project Analysis: (434 vars / 720 cases) - contains repeating questions and scores taken at baseline, 12 weeks, 24 weeks, and 48 weeks

Response Rates View help for 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.

Presence of Common Scales View help for 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)

Original Release Date View help for Original Release Date

2022-12-14

Version History View help for Version History

Weight View help for Weight

None