Lasmiditan May Be Effective as Acute Migraine Treatment
Lasmiditan is a novel centrally acting serotonin agonist with specificity for the 1F serotonin receptor, which was not found to have vasoconstrictive effects.
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LAS VEGAS — Lasmiditan was found to be more effective compared with placebo in eliminating pain and other symptoms associated with headache in individuals with migraine, in a study presented during the 2018 PAINWeek conference, held September 4-8.
Lasmiditan is a novel, centrally acting serotonin agonist with specificity for the 1F serotonin receptor, which was not found to have vasoconstrictive effects.
Study participants were from 2 clinical trials, SAMURAI and SPARTAN (ClinicalTrials.gov identifiers NCT02439320 and NCT02605174, respectively), and had a Migraine Disability Assessment Score ≥11 (moderate disability) and 3 to 8 attacks of migraine per month. Participants were randomly assigned to receive a first dose of treatment (SAMURAI: 1:1:1 ratio of lasmiditan, 200 mg; lasmiditan 100 mg; or placebo; SPARTAN: 1:1:1:1 ratio of lasmiditan, 200 mg; lasmiditan, 100 mg; lasmiditan, 50 mg; or placebo). The treatment was taken within 4 hours of migraine onset. For patients in need of rescue treatment, or those with recurring migraines, a second dose of the same drug as the initial dose was assigned.
The percentage of participants in each group who were headache pain-free and most bothersome symptom-free (2 hours after the first dose) were the study's primary and secondary outcomes, respectively.
In the SAMURAI trial, 32.2% of participants who had received lasmiditan, 200 mg were headache pain-free compared with 15.3% of participants in the placebo group (P <.001), and 40.7% vs 29.5%, respectively, were also most-bothersome symptom-free (P <.001). In the SPARTAN trial; a greater percentage of participants who had received lasmiditan, 200 mg vs placebo were headache pain-free (38.8% vs 21.3%; P <.001), and most-bothersome symptom-free (48.7% vs 33.5%; P <.001). Results were comparable in participants who had received lasmiditan at 100 mg and 50 mg compared with placebo.
The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy, and most events were mild to moderate in severity.
Wietecha LA, Kuca B, Asafu-Adjei J, et al. Phase 3 studies (SAMURAI, SPARTAN) of lasmiditan compared to placebo for acute treatment of migraine. Presented at: PAINWeek 2018; September 4-8, 2018; Las Vegas, NV. Poster 70.
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