Groundbreaking Chronic Migraine Study Enrolling Now
All of us who struggle with Migraine disease know that there's an enormous need for more research into Migraine. Yes, we need more research to find new and better treatments, but there are other types of research we need also. We need more research into the epidemiology and pathophysiology of Migraine, and we need research to answer specific questions about treating Migraine.
The good news is that there's a trial currently enrolling to answer one of the specific questions about treating Migraine. The trial is the Medication Overuse Treatment Strategy (MOTS) Trial. It's designed to answer questions that are very important to people with chronic Migraine. One of the biggest challenges to all of us with chronic Migraine is that using acute medications more than two or three days a week can very easily lead us to another problem, medication overuse headache (MOH).
Before I tell you more about this important study, let's discuss MOH a bit. First, I realize that the name "medication overuse headache" is a problem for some people. Let me assure you that it's just a name. Nobody associated with the study is passing judgement or blaming anyone who finds themselves in an MOH situation.
For anyone who isn't familiar with what MOH is or what can cause it, here's more info. The International Headache Society has set diagnostic and classification criteria for MOH that are quite complete in listing which medications can cause MOH in their International Classification of Headache Disorders, 3rd edition (ICHD-3). For a diagnosis of medication overuse headache, a pateint must experience at least 15 days of headache per month, and meet this criteria:
8.2 Medication-overuse headache (MOH)
8.2.1 Ergotamine-overuse headache Overuse defined as ergotamine intake on 10 or more days/month on a regular basis for more than 3 months.
8.2.2 Triptan-overuse headache
Overuse defined as triptan intake (any formulation) on 10 or more days/month on a regular basis for more than 3 months.
8.2.3 Analgesic-overuse headache
Overuse defined as intake of simple analgesics on 15 or more days/month on a regular basis for more than 3 months.
- 220.127.116.11 Paracetamol (acetaminophen)-overuse headache Regular intake of paracetamol on 15 days per month for more than 3 months.
- 18.104.22.168 Acetylsalicylic acid-overuse headache Regular intake of acetylsalicylic acid on 15 days per month for more than 3 months.
- 22.214.171.124 Other non-steroidal anti-inflammatory drug (NSAID)-overuse headache
Regular intake of one or more NSAIDs other than acetylsalicylic acid on 15 days per month for more than 3 months.
8.2.4 Opioid-overuse headache Overuse defined as intake of opioids on 10 or more days/month on a regular basis for more than 3 months.** Comment:** Studies show that patients overusing opioids have the highest relapse rate after withdrawal treatment.
8.2.5 Combination analgesic-overuse headache Overuse defined as intake of simple analgesic medications on 10 or more days/month on a regular basis for more than 3 months.** Note:** The term combination-analgesic is used specifically for formulations combining drugs of two or more classes, each with analgesic effect or acting as adjuvants.
8.2.6 Medication-overuse headache attributed to multiple drug classes not individually overused
Regular intake of any combination of ergotamine, triptans, simple analgesics, NSAIDs and/or opioids on a total of 10 days per month for more than 3 months without overuse of any single drug or drug class alone.
As you can see, any acute medication (medication used to treat a Migraine or headache when it occurs) can, if overused, cause MOH. Even alternating the types of acute medications leaves us vulnerable to MOH (see 8.2.6 above).
More about the study:
This video by Dr. David Dodick, one of the primary investigators of the MOTS trial is a good introduction to the study:
The aim of this study is to compare two real-world strategies for treating patients who have chronic migraine with medication overuse, each with evidence for effectiveness:
- Transition from the overused acute medication used during migraine attacks to different acute medication (prescribed with parameters to avoid medication overuse) with optimized preventive treatment;
- Optimized preventive treatment without transition from the overused acute medication.
Although both of these treatment strategies are commonly used, there's insufficient evidence to know if one of these methods is superior to the other or if they provide similar outcomes.
Patients participating in the study will be randomly assigned to one of two treatment arms matching the two strategies. It's very important to understand that patients who are randomized into the transition arm, will NOT be left without acute treatments. The treatments causing medication overuse will be discontinued, BUT other treatments will be prescribed to take their place.
There are no experimental treatments being used in this study. Participants must be patients at one of the study locations or become patients at one of them so they get consistent treatment from their own physician during the study. Centers participating in the study include Migraine and headache centers, general neurology practices, and family medicine practices. Centers participating in this study include:
- Northern Arizona Healthcare Medical Group; Flagstaff, Arizona
- Mayo Clinic in Arizona Headache Center; Phoenix, Arizona
- Mayo Clinic in Arizona Neurology Center; Phoenix, Arizona
- Pinnacle Internal Medicine and Headache Center; Phoenix, Arizona
- Mayo Clinic Thunderbird; Scottsdale, Arizona
- Orange County Migraine and Headache Center; Irvine, California
- Cedars-Sinai Medical Center; Los Angeles, California
- University of Colorado Denver Colorado Headache Center; Aurora, Colorado
- University of Colorado Denver Primary Center; Denver, Colorado
- Mayo Clinic Florida Headache Center; Jacksonville, Florida
- Brigham Women's Hospital Headache Clinic; Boston, Massachusetts
- Brigham Women's Hospital Neurology Clinic; Boston, Massachusetts
- Mayo Clinic Headache Center; Rochester, Minnesota
- DENT Neurologic Institute Amherst, New York
- University of Cincinnati Neurology; Cincinnati, Ohio
- University of Cincinnati Primary; Cincinnati, Ohio
- University of Cincinnati Headache Center; Dayton, Ohio
- Toledo Clinic General Neurology; Toledo, Ohio
- Thomas Jefferson University Hospital Headache Center; Philadelphia, Pennsylvania
- Preferred Headache Center; Pittsburgh, Pennsylvania
- University of Utah Primary Care; Salt Lake City, Utah
- University of Utah General Neurology; Salt Lake City, Utah
- University of Utah Headache Center; Salt Lake City, Utah
- Medical College of Wisconsin; Milwaukee, Wisconsin
The primary investigators for the MOTS trial are Dr. Todd Schwedt and Dr. David Dodick, both at the Mayo Clinic Headache Center in Arizona. I'm honored to be their co-investigator for this trial, my first venture into research. The study is funded by the Patient Centered Outcomes Research Institute (PCORI).
If you have chronic Migraine and medication overuse, I hope you'll consider being part of this important study. It's an opportunity to address your Migraine treatment AND to help answer this important question that so many of us face.
For more information:
- Visit the MOTS Trial web site.
- Check out the MOTS Trial Facebook page.
- Follow @MOTSTrial on Twitter.
- Click the "Email Me" button to the right or at the bottom of this page, depending on how you're viewing this post, to send me an email.
because a migraine is NOT "just a headache"
drawing on our inner Ninja to live a full life