According to study results published in BMC Neurology, a second dose of lasmiditan showed evidence of efficacy in treating migraine recurrence; however, benefit of a second dose as rescue treatment for persistent symptoms was not demonstrated. The investigators of this study examined the efficacy and safety of a second dose of lasmiditan for both acute recurrent and rescue treatment in patients with migraine headache.
Investigators pooled data from the SAMURAI (NCT02439320) and SPARTAN (NCT02605174) studies in which individuals with migraine were randomly assigned to receive oral lasmiditan 50 mg, 100 mg, 200 mg, or a placebo. Randomization for the second dose also occurred at baseline and researchers randomly assigned patients in lasmiditan groups 2:1 to receive either the same dose of lasmiditan or a placebo for second dose; participants who received placebo as first dose also received a placebo for the second dose.
Patients self-administered the first dose of lasmiditan or placebo within 4 hours of the onset of a moderate to severe migraine attack; patients could take a second dose for rescue or recurrence. Second dose was defined as a rescue dose if a participant was not pain-free at 2 hours and took a second dose 2 to 24 hours after the first dose, and defined as a recurrence dose if a participant reported being pain-free at 2 hours but later experienced a recurrence of migraine pain and took a second dose 2 to 24 hours after the first dose.
Compared with placebo, the proportion of participants who took a second dose was lower with lasmiditan and the strength of assigned lasmiditan dosage was inversely related to the number of participants who took a second dose. The proportion of participants who self-administered a second dose was 60% in the placebo group, 46% in the lasmiditan 50-mg group, 43% in the lasmiditan 100-mg group, and 36% in the 200-mg group. Most patients taking lasmiditan who needed a second dose did so for rescue treatment rather than recurrence.
Participants who were assigned to a first dose of lasmiditan reported similar efficacy outcomes (pain-free, pain relief, and free from most-bothersome symptoms) 2 hours after a second dose taken as rescue treatment, whether the second dose was lasmiditan or placebo (P >.05). Efficacy outcomes measured 2 hours after a second dose taken for recurrence were as follows: pain-free, 50% vs 32% (P >.05); pain relief, 77% vs 52% (P =.03); and free of most-bothersome symptoms, 71% vs 41% (P =.02). In participants assigned to a first dose of lasmiditan, the incidence of treatment-emergent adverse events from lasmiditan or placebo as second dose was similar; the most frequently reported adverse effects after a second dose were dizziness, paresthesia, fatigue, asthenia, nausea, and somnolence.
Limitations of the study included the smaller number of participants who took a second dose of lasmiditan for migraine recurrence, which limited power to detect group differences, and the exploratory nature of the analyses in which no adjustments were made for multiple comparisons.
The study results suggested that a second dose of lasmiditan shows evidence of efficacy for migraine recurrence; however, a second dose as rescue treatment was found to be ineffective. Reported adverse events were similar for a second dose of lasmiditan or placebo, indicating that the safety profile was not worsened by administration of a second dose of lasmiditan.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Loo LS, Plato BM, Turner IM, et al. Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN). BMC Neurol. 2019;19(1):191.