PHOENIX — A Mayo Clinic research team, led by neurologists Todd Schwedt, M.D. and David Dodick, M.D., has been approved for $7 million in funding from the Patient-Centered Outcomes Research Institute (PCORI) to study migraine treatment strategies.
The five-year study, “Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse,” will compare two current strategies for treating patients who have chronic migraine.
“For the first time, we will be able to directly compare two commonly used treatment strategies for those with chronic migraine and medication overuse. The results will help determine the optimal treatment strategy for patients with this common and disabling condition,” says Dr. Schwedt, adding that the trial is expected to begin later in 2016 and is expected to involve 1,280 enrolled patients.
Approximately 36 million people in the U.S. suffer from migraines and three percent of people (or roughly 10 million) suffer from chronic migraine, according to the American Migraine Foundation. Chronic migraine is defined as having at least 15 days of headache per month, including at least eight days per month of migraine.
About half of chronic migraine sufferers take medication to stop an attack too frequently, which could lead to medication overuse. Medication overuse can lead to more frequent migraines and migraines that are less responsive to other types of treatments. Mayo Clinic’s study will research the effects of immediate discontinuation of the overused medication plus treatment with migraine prophylactic therapy versus migraine prophylactic therapy without immediate discontinuation of the overused medication.
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Dr. Schwedt’s study was selected for funding through PCORI’s Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a diverse range of patients and care situations, and can be more quickly taken up in clinical practice.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders in a major study conducted in real-world settings, but also for its potential to answer an important question about migraines and fill a crucial evidence gap,” says Joe Selby, M.D., MPH, executive director, PCORI. “We look forward to following the study’s progress and working with Mayo Clinic to share its results.”
Mayo Clinic’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. For more information about PCORI’s funding, visit www.pcori.org.
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