Systematic review of outcomes and endpoints in acute migraine clinical trials

CONCLUSION: Acute migraine clinical trials exhibit 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. There were 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). Other aspects of acute migraine clinical trial design did not follow guidance. For example, multi-item PROMs intended to measure constructs (e.g., scales) are rarely used, the use of pain-related outcomes is inconsistent, some associated symptom assessments are idiosyncratic, and the timing of the assessment of primary endpoints is variable. 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.PMID:33611818 | DOI:10.1111/head.14067

Source: Headache - February 21, 2021 Category: Neurology Authors: Carrie R Houts James S McGinley Tracy K Nishida Dawn C Buse R J Wirth David W Dodick Peter J Goadsby Richard B Lipton Source Type: research