Abstract Details

CENTURION assessed lasmiditan’s efficacy and consistency in acute treatment of migraine across 4 attacks. 

We present findings from multicenter, placebo-controlled, double-blind Phase3 CENTURION study.

Patients were randomized 1:1:1 to lasmiditan 200mg; lasmiditan 100mg; or control group that received placebo for 3 attacks and lasmiditan 50mg for either the third/fourth attack(1:1). Primary endpoints: pain freedom at 2h (first attack) and pain freedom at 2h in at least 2 of 3 attacks. 

Of 1613 randomized patients, 1471 (mean age:41 years; female:84%; Europe:76%,  N. America:12%, Asia:12%; MIDAS mean score:31.6) treated ≥1 migraine attack with study drug (control[n=500]/lasmiditan 100mg[ n=485]/lasmiditan200 mg[n=486]). All primary and gated secondary endpoints were met (p<0.001 in all cases). We present efficacy findings for the first attack. Pain freedom rates at 2h: placebo:8.4%; lasmiditan 100mg:25.8% (OR vs placebo, 3.8, with a therapeutic gain ~17%); lasmiditan 200mg:29.3% (OR=4.6; therapeutic gain ~21%). Both lasmiditan doses were significantly better than placebo for pain freedom at 1h, and pain relief at 2h (significant separation from placebo beginning at 30 and 60 minutes in 200mg and 100-mg group, respectively). In triptan-insufficient responders, lasmiditan was significantly superior to placebo for pain freedom at 2h.

Incidence of treatment-emergent SAEs was similar across treatment groups-control[n=2]:0.4% (both after treatment with placebo); lasmiditan 100mg[n=1]:0.2%, lasmiditan 200mg[n=2]:0.4%; there were no major cardiovascular events consistent with ischemia. Most frequent TEAEs with lasmiditan (≥2% in either dose group in the first attack): dizziness, paresthesia, fatigue, nausea, vertigo, somnolence, hypoesthesia, muscle weakness, asthenia, feeling abnormal. 

Lasmiditan was superior to placebo for all gated endpoints. During first attack, lasmiditan was significantly superior to placebo for pain freedom and pain relief beginning at 1h, and sustained pain freedom at 24 and 48h. Lasmiditan was efficacious in triptan-insufficient responders. These results confirm the early and sustained efficacy of lasmiditan.