Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. (March 2021)

• Record Type: Journal Article
• Authors: Ashina, Messoud; Reuter, Uwe; Smith, Timothy; Krikke-Workel, Judith; Klise, Suzanne R; Bragg, Sonja; Doty, Erin G; Dowsett, Sherie A; Lin, Qun; Krege, John H
• Is Part Of: Cephalalgia. Volume 41:Number 3(2021)
• Page Start: 294
• Page End: 304
• Publication Date: 2021-03
• Subjects: Phase 3 -- lasmiditan -- efficacy -- consistency -- 5-HT1F receptor agonist; Headache -- Periodicals; 616.8491
• DOI: 10.1177/0333102421989232
• Languages: English
• ISSNs: 0333-1024

Abstract

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