Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study
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- Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study
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Background: We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods: Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results: Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg (p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions: These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810
Originalsprog | Engelsk |
---|---|
Tidsskrift | Cephalalgia |
Vol/bind | 41 |
Udgave nummer | 3 |
Sider (fra-til) | 294-304 |
Antal sider | 11 |
ISSN | 0333-1024 |
DOI | |
Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The CENTURION study was sponsored by Eli Lilly and Company.
Funding Information:
We are grateful to all study sites and patients who participated, in Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Mexico, The Netherlands, The Russian Federation, Spain, Switzerland, the United Kingdom, and the United States. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The CENTURION study was sponsored by Eli Lilly and Company.
Publisher Copyright:
© International Headache Society 2021.
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