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Determining the optimal treatment strategy for patients who have chronic migraine with medication overuse
Investigator (PI): Schwedt, Todd
Performing Organization (PO): (Current): Mayo Clinic, Department of Neurology / (480) 301-8000
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/PCS-1504-30133
Funding: Total Award Amount: $7,739,297
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Over 7 million Americans have chronic migraine, meaning that they have >15 days with headaches/month, including >8 days/month on which they have full-blown migraine attacks. One-half of people with chronic migraine take medications to abort migraine attacks too frequently, a condition that the scientific community calls "medication overuse." Medication overuse can lead to more frequent migraines, migraines that are less responsive to other treatments, and to numerous medication-related side effects and toxicities. Despite medication overuse being exceedingly common among people who have migraine and despite the importance of offering optimal treatment to patients who overuse medication, the best treatment strategy for patients who have chronic migraine with medication overuse is uncertain. Achievable outcomes: 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: early discontinuation of the overused medication plus treatment with migraine prophylactic therapy and migraine prophylactic therapy without early discontinuation of the overused medication. Although both of these treatment strategies are commonly used, it is not known if one of these methods is superior to the other or if they provide similar outcomes. Since early discontinuation of the overused medication can result in a transient period of increased migraine pain and greater migraine-related functional impairment, if the two treatment strategies provide similar outcomes, migraine prophylactic therapy without early discontinuation of the overused medication would be the preferred treatment. Patient and stakeholder engagement: Patients and other stakeholders have been and will continue to be integrally involved with all aspects of this study. Patients have roles as co-investigators and steering committee members for this study. Furthermore, patients without other formal roles on this study have filled out surveys in order to give their opinions regarding different aspects of this study and have participated in focus-group meetings with the investigators. The patient organization, the American Headache and Migraine Association (AHMA), is supporting this research. Patient stakeholders will continue to be involved in all aspects of this study, including determination of study design, monitoring the conduct of the research, and disseminating study results. Other stakeholders who are involved with and support this study include the American Headache Society, the National Headache Foundation, the International Headache Society, the Migraine Research Foundation, the American Migraine Foundation, the Headache and Facial Pain Section of the American Academy of Neurology, the Alliance for Headache Disorders Advocacy, and Mayo Clinic Health Solutions MMSI.
MeSH Terms:
  • Chronic Disease
  • Comparative Effectiveness Research
  • Focus Groups
  • Humans
  • Migraine Disorders /*drug therapy
  • /*prevention & control
  • Outcome Assessment (Health Care)
  • Patient Participation
  • * Prescription Drug Overuse
  • United States
Country: United States
State: Arizona
Zip Code: 85259
UI: 20162199
CTgovId: NCT02764320
Project Status: Ongoing
Record History: ('2018: Project extended to 2022',)