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Systematic review of outcomes and endpoints in acute migraine clinical trials

Headache: The Journal of Head and Face Pain Feb 28, 2021

Houts CR, McGinley JS, Nishida TK., et al. - Following a prespecified (but unregistered) protocol created to adhere to recommendations of the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses, researchers conducted a systematic literature review to examine the acute migraine clinical trial literature and to summarize the endpoints and outcomes used in such trials. In the analysis, 705 out of 1,567 publications found through the initial search and reference section reviews, were included for data extraction. It has been reported that acute migraine clinical trials show a large amount of variability in outcomes and endpoints used, in addition to the variability in how outcomes and endpoints were used from trial‐to‐trial. The study found some common elements across trials that align with guidance from the International Headache Society, the Food and Drug Administration and other regulatory agencies (e.g., assessing pain and associated symptoms, 2‐hour post‐treatment). This study’s findings demonstrated that the development of a core set of outcomes and endpoints for acute migraine clinical trials that are patient‐centered and statistically robust could improve the conduct of individual trials, facilitate cross‐trial comparisons, and better support informed treatment decisions by healthcare professionals and patients.

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