Abstract
Background:
Although guidelines for clinical trials have proposed a definition for a migraine day, randomised clinical trials tend to vary in their definition used.
Methods:
Definitions of a migraine day in phase III trials with monoclonal antibodies and small molecules targeting the calcitonin gene-related peptide pathway for the preventive treatment of migraine were compared.
Results:
Twelve different definitions were found across 23 trials. Variation in headache duration, the inclusion or exclusion of probable migraine and the inclusion or exclusion of a treated migraine attack with a specific or non-specific drug were most subject to debate. No single criterium or set of criteria was common to all definitions used. The most common single criterium used was a minimal headache duration of at least 30 minutes where only two clinical trials allowed for a headache with a shorter duration to be included.
Conclusion:
There is a pressing need for a standardised accepted definition of a migraine day both from a clinical and research perspective.
| Original language | English |
|---|---|
| Pages (from-to) | 3331024251393986 |
| Journal | Cephalalgia : an international journal of headache |
| Volume | 45 |
| Issue number | 11 |
| DOIs | |
| Publication status | E-pub ahead of print - 5 Nov 2025 |
Bibliographical note
Publisher Copyright:© International Headache Society 2025. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).