Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial. (5th April 2022)

• Record Type: Journal Article
• Authors: Schwedt, Todd J.; Hentz, Joseph G.; Sahai-Srivastava, Soma; Murinova, Natalia; Spare, Nicole M.; Treppendahl, Christina; Martin, Vincent T.; Birlea, Marius; Digre, Kathleen; Watson, David; Leonard, Michael; Robert, Teri; Dodick, David W.
• Other Names: author non-byline.; Ahmed Zubair author non-byline.; Bennett Nathan author non-byline.; Blaya Maike Tiede author non-byline.; Cortez Melissa author non-byline.; Cutrer Michael author non-byline.; David Paru author non-byline.; Delange Justin author non-byline.; Goldstick Lawrence author non-byline.; Harter Christine author non-byline.; Hutchinson Susan author non-byline.; Kennebeck Greg author non-byline.; Lane Judy author non-byline.; Mechtler Laszlo author non-byline.; Monteith Tesha author non-byline.; Mullally William author non-byline.; O'Carroll Cumara author non-byline.; Pippitt Karly author non-byline.; Plato Brian author non-byline.; Rau Jill author non-byline.; Razzaghi Mitra author non-byline.; Rizzoli Paul author non-byline.; Schecht Howard author non-byline.; Smith Tim author non-byline.; True David author non-byline.; Wald John author non-byline.
• Is Part Of: Neurology. Volume 98:Number 14(2022)
• Page Start: e1409
• Page End: e1421
• Publication Date: 2022-04-05
• Subjects: Neurology -- Periodicals; Neurology -- Periodicals; Neurologie -- Périodiques; 616.8
• DOI: 10.1212/WNL.0000000000200117
• Languages: English
• ISSNs: 0028-3878

Abstract

Abstract : Background and Objectives: Overuse 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. Methods: The 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. Results: Seven 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). Discussion: When 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 Information: ClinicalTrials.gov identifier NCT02764320. Classification of Evidence: This 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.