One of the most difficult situations a Migraineur can experience is having both chronic Migraine (CM) and medication overuse (MOH).Medication overuse has long been a catch-22 and a thorn in the sides of Migraine patients for a couple of reasons:
- We’re stuck with the question of what we can do for a Migraine attack once we’ve used our acute medications as many days in a week as we can without risking MOH.
- Preventive treatments might not work as well for us if we’re in a state of medication overuse.
To add to these issues, there’s another one — the best treatment strategy for those of us with simultaneous chronic Migraine and medications overuse is uncertain. Doctors have been using two different treatment strategies for these patients, but there’s insufficient evidence as to which of the two is better.You may think this is a perfect question for a research study, as do I. The problem is that research is quite expensive. This isn’t the kind of research that pharmaceutical companies can conduct because their shareholders expect their research to result in a marketable product. Funding from the National Institutes for Health (NIH) isn’t based on disease burden, and Migraine and headache research funding from them has long been inequitable and inadequate.
I’m thrilled to be able to tell you that the Patient Centered Outcomes Research Institute (PCORI), is funding a five-year study to address the question of which of the two treatment protocols currently in use for patients with both CM and MOH is better. The study is called the Medication Overuse Treatment Strategy Trial (MOTSTrial), and 30 sites around the United States are beginning to enroll participants. The sites fall into three categories:
- Migraine and headache specialty
- general neurology
- primary care
This is a pragmatic study, which means that it aims to evaluate the effectiveness of an intervention in the usual clinical setting. The specific aim of the MOTSTrial is to compare the two real-world strategies for treating patients who have chronic Migraine with medication overuse, each with evidence for effectiveness. Doctors are currently using both of the strategies below, but theres no consensus and inadequate evidence to say if one of these methods is superior to the other or if they provide similar outcomes. Study participants will be randomly assigned to one of two treatment strategies:
- Discontinuation of the overused medication plus treatment with Migraine prophylactic (preventive) therapy
- Migraine prophylactic therapy without early discontinuation of the overused medication
No trial or experimental treatments will be used in this study. Participants will be treated as their doctors would normally treat them with the exception of utilizing one of the two treatment strategies above. Which preventive therapies are used is a decision to be made by the doctor and patient, not mandated by the study.
Patients who participate in the study will participate for 12 months.To be eligible to participate in the study, participants must be a patient at one of the participating study sites. They must also:
- be adults, at least 21 years of age
- have chronic Migraine – diagnosed according to ICHD-3 beta criteria
- be in a state of medication overuse – diagnosed according to ICHD-3 beta criteria
- be willing to be randomized to either of the two treatment arms
- be willing to maintain a migraine and headache diary
- plan for follow-up care with the clinician
Patients will be excluded from the trial if:
- they are younger than 21 years of age
- they have headache disorder diagnoses other than chronic Migraine with medication overuse
- they are not willing to be randomized to either of the treatment arms
- they are not willing to maintain a daily Migraine and headache diary
- they are not planning on follow-up care with the clinician
- in the opinion of the clinician, outpatient discontinuation of the overused medication is considered unsafe
- in the opinion of the clinician, treatment with preventive medications is considered unsafe (e.g. pregnancy)
Summary and comments:
Todd Schwedt, M.D., and David Dodick, M.D., both at the Mayo Clinic in Arizona, are the primary investigators on this trial. I’m honored that they asked me to be their co-investigator. Part of my job is to disseminate information about the trial as it becomes available. This post gives you some of the basics about the trial. I’ll give you some additional links below. At this time, sites are enrolling trial participants. With participants from different types of medical practices, we’ll be accumulating data from a wide range of patients, not just those who are treated by Migraine and headache specialists.This video with Dr. Dodick gives a good overview of the study:
Over the total trial period, I’ll be updating you with information as it’s ready to be released. I will not, of course, disclose anything before it’s approved to be released to the public, nor will I violate anyone’s privacy.For more information about the Medication Overuse Treatment Strategy Trial, visit:
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Teri Robert is a leading patient educator and advocate and the author of Living Well with Migraine Disease and Headaches. A co-founder of the Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association, she received the National Headache Foundation’s Patient Partners Award and a Distinguished Service Award from the American Headache Society. Teri can be found on her website, and blog, Facebook, Twitter, StumbleUpon, Pinterest, LinkedIn, and Google+.