Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2025 Feb;45(2):3331024251320610.
doi: 10.1177/03331024251320610.

Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials

Peter J Goadsby  1   2 , Tim P Jürgens  3   4 , Elimor Brand-Schieber  5 , Krisztian Nagy  6 , Yingyi Liu  5 , Ramesh Boinpally  5 , Sven Stodtmann  7 , Joel M Trugman  5
Affiliations
Free article
Meta-Analysis

Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials

Peter J Goadsby et al. Cephalalgia. 2025 Feb.
Free article

Abstract

Background: Published evidence supporting efficacy of calcitonin gene-related peptide receptor antagonists as acute migraine treatments in males is limited.

Methods: To fill the gap, we present male and female data from four ubrogepant and four atogepant randomized, double-blind, placebo-controlled trials for acute and preventive treatment of migraine, respectively. Acute outcomes included 2-h pain freedom and absence of most bothersome symptom (co-primary; headache-phase randomized, double-blind, placebo-controlled trials); absence of moderate-to-severe headache within 24 h (primary; prodrome randomized, double-blind, placebo-controlled trial). Preventive outcome included change from baseline in mean monthly migraine days across 12 weeks (primary).

Results: Pooled data from phase 3 headache-phase ubrogepant randomized, double-blind, placebo-controlled trials showed similar rates of pain freedom (19.4% vs 21.1%) and absence of most bothersome symptom (35.1% vs 39.0%) 2 h post-dose between males and females, respectively. Time course of pain freedom and absence of most bothersome symptom over 48 h was similar between male and female subgroups. Comparable reductions in mean monthly migraine days across 12-week treatment periods were found between males and females treated with atogepant 60 mg once-daily in pooled episodic migraine and chronic migraine randomized, double-blind, placebo-controlled trials.

Conclusion/interpretation: In ubrogepant and atogepant randomized, double-blind, placebo-controlled trials, although analysis power for males is limited due to small sample sizes, evidence supports similar treatment effects in males and females with migraine.

Trial registration: ClinicalTrials.gov: NCT02828020; NCT02867709; NCT04492020; NCT01613248; NCT02848326; NCT03777059; NCT04740827; NCT03855137.

Keywords: Episodic migraine; calcitonin gene–related peptide; chronic migraine; gepants; sexual dimorphism.

PubMed Disclaimer

Conflict of interest statement

Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: P.J.G. reports, over the last 36 months, grants from Kallyope; personal fees from AbbVie, Aeon Biopharma, Amgen, CoolTech LLC, Dr Reddy's, Eli Lilly and Company, eNeura, Epalex, Linpharma, Lundbeck, Man & Science, Pfizer, Sanofi, Satsuma, Shiratronics, Teva Pharmaceuticals, and Vial; personal fees for advice through Gerson Lehrman Group, Guidepoint, SAI Med Partners, and Vector Metric; fees for educational materials from CME Outfitters; publishing royalties or fees from Massachusetts Medical Society, Oxford University Press, UptoDate, and Wolters Kluwer; and a patent magnetic stimulation for headache (No. WO2016090333 A1) assigned to eNeura without fee. T.P.J. reports research grants from Novartis, personal fees from AbbVie, Allergan, Grünenthal, Hormosan, Lilly, Lundbeck, Novartis, Pfizer, Sanofi, and Teva, and publishing royalties from Elsevier. J.M.T., E.B.S., K.N., Y.L., R.B., and S.S. are employees of AbbVie and may hold AbbVie stock.

Publication types

Associated data

LinkOut - more resources