An Assessment of Sex and Gender Considerations in Migraine Calcitonin Gene-Related Peptide Clinical Trials.

Background: Published guidelines for conducting clinical trials for migraine therapeutics recommend recruiting participants based on disease epidemiology and including sex/gender-based subpopulation analyses. These recommendations aim to improve the quality and generalizability of migraine clinical trials. The aim of this study was to summarize participant demographics in migraine clinical trials for FDA-approved calcitonin gene-related peptide (CGRP)-targeting drugs (receptor antagonists [gepants], CGRP peptide or receptor monoclonal antibodies [mAbs]) and assess the use of sex/gender-based subpopulation analyses in these studies.

Methods: We conducted a review of industry-sponsored migraine clinical trials for FDA-approved CGRP-targeting medications. Demographic data (sex and/or gender) from phase II or III trials were abstracted, and the use of sex/gender-based analyses was recorded.

Results: Fourteen trials of gepants were included in this analysis. Participants who were identified as females or women were more likely to participate in these trials (87.0 ± 2.2%). Twenty-four trials of CGRP mAbs were reviewed. These studies also reported that participants were predominantly identified as female or women (84.9 ± 2.3%). None of the clinical trials reviewed reported sex/gender-based analyses of their results.

Conclusions: This study suggests that men are underrepresented in migraine CGRP clinical trials. Greater attention to sex and gender is needed in migraine clinical trial design so that they better align with current recommendations made by headache societies and regulatory agencies.