TY - JOUR
T1 - Patient-Centered Treatment of Chronic Migraine With Medication Overuse
T2 - A Prospective, Randomized, Pragmatic Clinical Trial
AU - MOTS Investigators
AU - Schwedt, Todd J.
AU - Hentz, Joseph G.
AU - Sahai-Srivastava, Soma
AU - Murinova, Natalia
AU - Spare, Nicole M.
AU - Treppendahl, Christina
AU - Martin, Vincent T.
AU - Birlea, Marius
AU - Digre, Kathleen
AU - Watson, David
AU - Leonard, Michael
AU - Robert, Teri
AU - Dodick, David W.
AU - Ahmed, Zubair
AU - Bennett, Nathan
AU - Blaya, Maike Tiede
AU - Cortez, Melissa
AU - Cutrer, Michael
AU - David, Paru
AU - Delange, Justin
AU - Goldstick, Lawrence
AU - Harter, Christine
AU - Hutchinson, Susan
AU - Kennebeck, Greg
AU - Lane, Judy
AU - Mechtler, Laszlo
AU - Monteith, Tesha
AU - Mullally, William
AU - O'Carroll, Cumara
AU - Pippitt, Karly
AU - Plato, Brian
AU - Rau, Jill
AU - Razzaghi, Mitra
AU - Rizzoli, Paul
AU - Schecht, Howard
AU - Smith, Tim
AU - True, David
AU - Wald, John
N1 - Funding Information:
Todd Schwedt reports that his institution received funding from PCORI for conducting this clinical trial. Schwedt has received personal compensation from Abbvie, Alder, Allergan, Amgen, Biohaven, Cipla, Click Therapeutics, Dr. Reddy's, Eli Lilly, Equinox, Lundbeck, Novartis, Teva, Tonix, Weber and Weber, and XoC; stock options from Aural Analytics, Nocira, and Second Opinion; royalties from UpToDate; research grants from American Migraine Foundation, Amgen, Henry Jackson Foundation, NIH, Spark Neuro, and US Department of Defense, all outside of the submitted work. Joseph Hentz reports that his institution received funding from PCORI for conducting this clinical trial. Soma Sahai-Srivastava reports that her institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Sahai-Srivastava has received personal compensation from Teva, Eli Lilly, and Amgen, outside of the submitted work. Natalia Murinova reports that her institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Nicole Spare reports that her institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Spare has received personal fees from Amgen/Novartis, Abbvie, Teva, and Biohaven, outside of the submitted work. Christina Treppendahl reports that her institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Vincent Martin reports that his institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Marius Birlea reports that his institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Kathleen Digre reports that her institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Digre has received royalties from Elsevier and Springer, outside of the submitted work. David Watson reports that his institution received funding from Mayo Clinic/PCORI for conducting this clinical trial. Michael Leonard reports that his institution received funding from PCORI for conducting this clinical trial. Teri Robert received funding from Mayo Clinic/PCORI for serving as a coinvestigator on this clinical trial. David Dodick reports that his institution received funding from PCORI for conducting this clinical trial. Dodick has received personal compensation for consulting from AEON, Amgen, Atria, Clexio, Cerecin, Cooltech, Ctrl M, Allergan, Alder, Biohaven, GSK, Linpharma, Lundbeck, Promius, Eli Lilly, eNeura, Novartis, Impel, Satsuma, Theranica, WL Gore, Nocira, XoC, Zosano, Upjohn (Division of Pfizer), Pieris, Praxis, Revance, and Equinox; personal compensation as honoraria from Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, MJH Lifesciences, Miller Medical Communications, Southern Headache Society (MAHEC), WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, and Cambridge University Press; stock options from Ctrl M, Aural analytics, ExSano, Palion, Healint, Theranica, Second Opinion/Mobile Health, Epien, Nocira, Matterhorn, Ontologics, King-Devick Technologies, and Precon Health; and research support from Department of Defense, NIH, Henry Jackson Foundation, Sperling Foundation, and American Migraine Foundation; all outside of the submitted work. Go to Neurology.org/N for full disclosures.
Funding Information:
Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (PCS-1504-30,133). The views in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors, or its Methodology Committee.
Funding Information:
Research reported in this article was funded through a PatientCentered Outcomes Research Institute (PCORI) award (PCS-1504-30,133). The views in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors, or its Methodology Committee.
Publisher Copyright:
© American Academy of Neurology.
PY - 2022/4/5
Y1 - 2022/4/5
N2 - Background and ObjectivesOveruse of symptomatic (i.e., acute) medications is common among those with chronic migraine. It is associated with developing frequent headaches, medication side effects, and reduced quality of life. The optimal treatment strategy for patients who have chronic migraine with medication overuse (CMMO) has long been debated. The study objective was to determine whether migraine preventive therapy without switching or limiting the frequency of the overused medication was noninferior to migraine preventive therapy with switching from the overused medication to an alternative medication that could be used on ≤2 d/wk.MethodsThe Medication Overuse Treatment Strategy (MOTS) trial was an open-label, pragmatic clinical trial, randomizing adult participants 1:1 to migraine preventive medication and (1) switching from the overused medication to an alternative used ≤2 d/wk or (2) continuation of the overused medication with no maximum limit. Participants were enrolled between February 2017 and December 2020 from 34 clinics in the United States, including headache specialty, general neurology, and primary care clinics. The primary outcome was moderate to severe headache day frequency during weeks 9 to 12 and subsequently during weeks 1 to 2 after randomization.ResultsSeven hundred twenty participants were randomized; average age was 44 (SD 13) years; and 87.5% were female. At baseline, participants averaged 22.5 (SD 5.1) headache days over 4 weeks, including 12.8 (SD 6.7) moderate to severe headache days and 21.4 (SD 5.8) days of symptomatic medication use. Migraine preventive medication without switching of the overused medication was not inferior to preventive medication with switching for moderate to severe headache day frequency during weeks 9 to 12 (switching 9.3 [SD 7.2] vs no switching 9.1 [SD 6.8]; p = 0.75, 95% CI -1.0 to 1.3). The treatment strategies also provided similar outcomes during the first 2 weeks (switching 6.6 [SD 3.7] moderate to severe headaches days vs no switching 6.4 [SD 3.6]; p = 0.57, 95% CI -0.4 to 0.7).DiscussionWhen reduction in moderate to severe headache days was used as the outcome of interest for the management of CMMO, migraine preventive medication without switching or limiting symptomatic medication is not inferior to migraine preventive medication with switching to a different symptomatic medication with a maximum limit of 2 treatment days per week.Trial Registration InformationClinicalTrials.gov identifier NCT02764320.Classification of EvidenceThis study provides Class III evidence that, for patients who have CMMO, migraine preventive medication without switching or limiting the overused medication is noninferior to migraine preventive medication with switching and limiting symptomatic medication.
AB - Background and ObjectivesOveruse of symptomatic (i.e., acute) medications is common among those with chronic migraine. It is associated with developing frequent headaches, medication side effects, and reduced quality of life. The optimal treatment strategy for patients who have chronic migraine with medication overuse (CMMO) has long been debated. The study objective was to determine whether migraine preventive therapy without switching or limiting the frequency of the overused medication was noninferior to migraine preventive therapy with switching from the overused medication to an alternative medication that could be used on ≤2 d/wk.MethodsThe Medication Overuse Treatment Strategy (MOTS) trial was an open-label, pragmatic clinical trial, randomizing adult participants 1:1 to migraine preventive medication and (1) switching from the overused medication to an alternative used ≤2 d/wk or (2) continuation of the overused medication with no maximum limit. Participants were enrolled between February 2017 and December 2020 from 34 clinics in the United States, including headache specialty, general neurology, and primary care clinics. The primary outcome was moderate to severe headache day frequency during weeks 9 to 12 and subsequently during weeks 1 to 2 after randomization.ResultsSeven hundred twenty participants were randomized; average age was 44 (SD 13) years; and 87.5% were female. At baseline, participants averaged 22.5 (SD 5.1) headache days over 4 weeks, including 12.8 (SD 6.7) moderate to severe headache days and 21.4 (SD 5.8) days of symptomatic medication use. Migraine preventive medication without switching of the overused medication was not inferior to preventive medication with switching for moderate to severe headache day frequency during weeks 9 to 12 (switching 9.3 [SD 7.2] vs no switching 9.1 [SD 6.8]; p = 0.75, 95% CI -1.0 to 1.3). The treatment strategies also provided similar outcomes during the first 2 weeks (switching 6.6 [SD 3.7] moderate to severe headaches days vs no switching 6.4 [SD 3.6]; p = 0.57, 95% CI -0.4 to 0.7).DiscussionWhen reduction in moderate to severe headache days was used as the outcome of interest for the management of CMMO, migraine preventive medication without switching or limiting symptomatic medication is not inferior to migraine preventive medication with switching to a different symptomatic medication with a maximum limit of 2 treatment days per week.Trial Registration InformationClinicalTrials.gov identifier NCT02764320.Classification of EvidenceThis study provides Class III evidence that, for patients who have CMMO, migraine preventive medication without switching or limiting the overused medication is noninferior to migraine preventive medication with switching and limiting symptomatic medication.
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U2 - 10.1212/WNL.0000000000200117
DO - 10.1212/WNL.0000000000200117
M3 - Article
C2 - 35169011
AN - SCOPUS:85128244915
VL - 98
SP - E1409-E1421
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 14
ER -