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Clinical Trial
. 2024 Dec;44(12):3331024241300305.
doi: 10.1177/03331024241300305.

Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials

Christopher Gottschalk  1 , Pranav Gandhi  2 , Patricia Pozo-Rosich  3   4 , Suzanne Christie  5 , Cristina Tassorelli  6   7 , Jonathan Stokes  2 , Yingyi Liu  2 , Lei Luo  2 , Krisztian Nagy  8 , Joel M Trugman  2 , Richard B Lipton  9
Affiliations
Free article
Clinical Trial

Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials

Christopher Gottschalk et al. Cephalalgia. 2024 Dec.
Free article

Abstract

Background: We aimed to assess the effects of preventive migraine treatment with atogepant vs. placebo on patient-reported quality of life and functioning.

Methods: Analyses of patient-reported outcomes from three 12-week, randomized, placebo-controlled trials evaluating preventive migraine treatment with atogepant 60 mg once-daily: ADVANCE (low-frequency episodic migraine [LFEM], 4-8 monthly migraine days [MMDs] and high-frequency episodic migraine [HFEM], 8-14 MMDs), PROGRESS (chronic migraine, CM) and ELEVATE (episodic migraine in those previously failed by two to four classes of oral preventive treatments).

Results: Least squares mean differences (95% confidence interval (CI)) in change from baseline were greater (p < 0.05) for atogepant vs. placebo for Migraine-Specific Quality of Life questionnaire Role Function-Restrictive domain scores at week 12 (ADVANCE: LFEM 12.0 (95% CI = 6.0-18.0), HFEM 9.9 (95% CI = 3.4-16.4); PROGRESS: 6.2 (95% CI = 2.5-9.8); ELEVATE: 17.7 (95% CI = 13.1-22.3)), for Headache Impact Test-6 total scores at week 12 (ADVANCE: LFEM -4.7 (95% CI = -6.7 to -2.7); HFEM -3.4 (95% CI = -5.5 to -1.2); PROGRESS: -2.8 (95% CI = -4.1 to -1.4); ELEVATE: -6.5 (95% CI = -8.3 to -4.7)) and for Activity Impairment in Migraine-Diary-Performance of Daily Activities scores across 12 weeks (ADVANCE: LFEM -2.3 (95% CI = -3.9 to -0.7), HFEM -4.5 (95% CI = -6.9 to -2.2); PROGRESS: -3.4 (95% CI = -5.3 to -1.5); ELEVATE: -4.7 (95% CI = -6.4 to -3.1)).

Conclusions: Preventive migraine treatment with atogepant 60 mg once-daily vs. placebo improved measures of migraine-related quality of life and functioning among participants with different headache frequencies and histories of previous treatment failure.Trial Registration: ClinicalTrials.gov: NCT03777059 (ADVANCE); NCT03855137 (PROGRESS); NCT04740827 (ELEVATE).

Keywords: atogepant; headache; migraine disorders; patient-reported outcome measures; quality of life.

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Conflict of interest statement

Declaration of conflicting interestsChristopher Gottschalk, MD, FAHS, has received personal fees as a consultant or member of an advisory board from AbbVie, Lundbeck, Pfizer, Spherix Global Insights, and Theranica; and is a trustee of the Headache Cooperative of the Northeast (HCNE); and does not hold any stock or options. Patricia Pozo-Rosich, MD, PhD, has received, in the last 3 years, personal fees for advisory boards and speaker panels from AbbVie, Amgen, Dr. Reddy’s, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer, and Teva, and for serving on the scientific advisory board of Lilly Foundation Spain and Gadea Science Foundation; is the principal investigator for clinical trials sponsored by AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva; has received (with her group) grants from AbbVie, ERANet Neuron, Instituto de Salud Carlos III, International Headache Society, Novartis, FEDER RIS3CAT, and Teva; serves as an associate editor for Cephalalgia, Headache, Neurologia, The Journal of Headache and Pain, and Revista de Neurologia; is the Honorary Secretary of the International Headache Society; and does not hold any stock or options. Suzanne Christie, MD, has received compensation for consulting and/or honoraria from Allergan (now AbbVie), Lilly, Novartis, and Teva; has participated on advisory boards for AbbVie, Lundbeck, and Miravo; and has received research support from Novartis. Cristina Tassorelli, MD, PhD, has participated in advisory boards for AbbVie, Dompé, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva; has lectured at symposia and is a principal investigator or collaborator in clinical trials sponsored by AbbVie, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva; has received research grants from the European Commission, Italian Ministry of Health, Italian Ministry of University, Migraine Research Foundation, and Italian Multiple Sclerosis Foundation; and serves as an associate editor for Cephalalgia. Jonathan Stokes, MBA; Krisztian Nagy, MD; Joel M. Trugman, MD; Lei Luo, MPH, BS; Yingyi Liu, PhD; and Pranav Gandhi, PhD, are employees of AbbVie and may hold AbbVie stock. Richard B. Lipton, MD, has received research support from the National Headache Foundation, the National Institutes of Health, and the US Food and Drug Administration; serves as consultant for, advisory board member of, or has received honoraria or research support from AbbVie/Allergan, Amgen, Biohaven, Dr. Reddy’s Laboratories (Promius), electroCore, Eli Lilly, GlaxoSmithKline, Lundbeck, Merck, Novartis, Teva, Vector, and Vedanta Research; receives royalties from Wolff’s Headache, 8th edition (Oxford University Press, 2009), and Informa; and holds stock/options in Axon, Biohaven, CoolTech, and Manistee.

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