OBJECTIVE: To assess the efficacy and safety of lasmiditan in the acute 
treatment of migraine.
METHODS: Adult patients with migraine were randomized (1:1:1) to a double-blind 
dose of oral lasmiditan 200 mg, lasmiditan 100 mg, or placebo and were asked to 
treat their next migraine attack within 4 hours of onset. Over 48 hours after 
dosing, patients used an electronic diary to record headache pain and the 
presence of nausea, phonophobia, and photophobia, one of which was designated 
their most bothersome symptom (MBS).
RESULTS: Of the 1,856 patients who treated an attack, 77.9% had ≥1 
cardiovascular risk factors in addition to migraine. Compared with placebo, more 
patients dosed with lasmiditan 200 mg were free of headache pain at 2 hours 
after dosing (32.2% vs 15.3%; odds ratio [OR] 2.6, 95% confidence interval [CI] 
2.0-3.6, p< 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 
2.2, 95% CI 1.6-3.0, p< 0.001). Furthermore, compared with those dosed with 
placebo, more patients dosed with lasmiditan 200 mg (40.7% vs 29.5%; OR 1.6, 95% 
CI 1.3-2.1, p< 0.001) and lasmiditan 100 mg (40.9%; OR 1.7, 95% CI, 1.3-2.2, p< 
0.001) were free of their MBS at 2 hours after dosing. Adverse events were 
mostly mild or moderate in intensity.
CONCLUSIONS: Lasmiditan dosed at 200 and 100 mg was efficacious and well 
tolerated in the treatment of acute migraine among patients with a high level of 
cardiovascular risk factors.
CLINICALTRIALSGOV IDENTIFIER: NCT02439320.
CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for adult 
patients with migraine, lasmiditan increases the proportion of subjects who are 
headache pain free at 2 hours after treating a migraine attack.