Abstract
BACKGROUND: Pain freedom after 2 hours is the recommended primary endpoint by the International Headache Society in randomized trials investigating drug treatment of acute migraine attacks. In order to demonstrate an early effect of a drug, some drug companies, however, have promoted headache relief (improvement from severe or moderate pain to mild or no pain) at earlier time points than 2 hours as outcome parameter.
METHODS AND RESULTS: We analyzed the relationship between pain freedom and headache relief in acute migraine trials and observed that persistent mild headache constituted 90% of headache relief after 0.5 hour and 40% of headache relief after 2 hours.
CONCLUSION: Headache relief at 2 hours should in our view only be used as an outcome measure for comparison with historic data. Prior to 2 hours, headache relief varies with time from intake and the therapeutic gain is very small. Therefore, pain freedom should be used at these early time points.
Original language | English |
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Journal | Cephalalgia : an international journal of headache |
Volume | 40 |
Issue number | 12 |
Pages (from-to) | 1331-1335 |
Number of pages | 5 |
ISSN | 0333-1024 |
DOIs | |
Publication status | Published - Oct 2020 |
Keywords
- controlled trials
- headache relief
- Migraine attack
- pain freedom
- treatment