Treatment-Emergent Adverse Events With Lasmiditan Use for Acute Migraine

woman, hands head, headache, migraine, pain
Study evaluated safety profile of lasmiditan based on findings from the 2 phase 3 studies (SPARTAN and SAMURAI) for the treatment of acute migraine.

The following article is part of conference coverage from the 2019 American Academy of Neurology Annual Meeting (AAN 2019) in Philadelphia, PA. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2019.

PHILADELPHIA — Lasmiditan is associated with quick onset, self-limiting mild to moderate treatment-emergent adverse events for the treatment of acute migraine, according to research presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10, 2019, in Philadelphia, Pennsylvania.

This study included 4439 participants with migraine assigned to lasmiditan 50 mg (n=654), 100 mg (n=1265), 200 mg (n=1258), and placebo (n=1262). Data was taken from the double-blind, phase 3 SPARTAN and SAMURAI studies ( identifier: NCT02605174 and NCT02439320, respectively). In each study, participants were instructed to take the dose within 4 hours of the start of a migraine attack. Randomized second doses could be taken when needed for rescue or recurrence.

Safety data from the 2 studies were integrated, with analysis performed on treatment-emergent adverse events within 2 days of the first dose.

There were 7 participants with serious adverse events (0.2% of placebo, 0.2% of lasmiditan 50 mg, 0.2% of lasmiditan 200 mg, and 0.2% of lasmiditan 200 mg groups) and no deaths. At least 1 treatment-emergent adverse event occurred in 13.5% (n=174) of placebo, 25.4% (n=166) of lasmiditan 50 mg, 36.2% (n=458) of lasmiditan 100 mg, and 40.3% (n=510) of lasmiditan 200 mg groups.

Most treatment-emergent adverse events in the lasmiditan groups were of mild or moderate severity, with the most significant being dizziness, paresthesia, drowsiness, fatigue, nausea, weak muscles, and hypoesthesia. The events had a median onset time of 0.50 to 0.85 hours and a median duration of 1.00 to 4.75 hours. No ischemic events occurred, and affirmative responses on the Columbia-Suicide Severity Rating Scale were low.

The study researchers concluded that “[as] a centrally-penetrant drug, lasmiditan use was associated with neurologic [treatment-emergent adverse events] most mild or moderate, of quick onset and self-limiting.”

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Disclosure: This study was funded by Eli Lilly and Company. All authors have disclosed affiliation with Eli Lilly and Company.

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Krege JH, Liffick E, Doty EG, Dowsett SA, Wang JN, Buchanan AS. Safety findings from the phase 3 studies (SAMURAI, SPARTAN) of lasmiditan for acute treatment of migraine. Presented at: 2019 American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. Abstract P1.10-009.