To identify the patient phenotype or the migraine attack characteristics predictive of achieving 2-hour pain freedom following oral lasmiditan for the acute treatment of migraine.

 Lasmiditan, a high-affinity, selective, 5-hydroxytryptamine 1F receptor agonist without vasoconstrictive activity, has proven to be effective in the acute treatment of migraine in 2 Phase 3 studies (SAMURAI [NCT02439320] and SPARTAN [NCT02605174]).

 Integrated analyses were completed from 2 similarly designed Phase 3, double-blind, studies SAMURAI (NCT02439320) and SPARTAN (NCT02605174). Key inclusion criteria: 3 to 8 migraine attacks/month and Migraine Disability Assessment Score (MIDAS) of at least 11 (moderate disability). Patients (N=3700) were randomized equally to receive lasmiditan (200 mg, 100 mg, 50 mg [SPARTAN only]) or placebo within 4 hours of onset of a migraine attack of at least moderate severity. Logistic regression models were used to identify statistically significant predictors associated with response. P-values were determined from tests of subgroup-by-treatment interaction with terms for study, subgroup (patient phenotype or migraine attack characteristic), treatment, and interaction.

 Both studies met the primary endpoint of 2-hour pain freedom for all lasmiditan doses. No patient phenotype was identified that predicted 2-hour pain freedom response to lasmiditan relative to placebo across dose groups, including gender, race (Caucasian vs non-Caucasian), ethnicity (Hispanic vs non-Hispanic), baseline body mass index, number of cardiovascular risk factors, concomitant topiramate or propranolol use, triptan use within prior 3 months, history of aura, migraine duration history, average migraine attacks/month in the 3 months prior to enrollment, and baseline MIDAS. No migraine attack characteristic predicted response including headache pain severity at time of treatment, time to treatment from migraine onset, presence of nausea, and migraine attack-related disability.

Lasmiditan's efficacy (2-hour pain freedom) is not influenced by patient phenotype or migraine characteristic parameters.