Abstract Details

Title Safety Findings from the Phase 3 Studies (SAMURAI, SPARTAN) of Lasmiditan for Acute Treatment of Migraine

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-009

Objective To assess the safety profile of lasmiditan based on findings from the Phase 3 studies, SPARTAN and SAMURAI.

Background Lasmiditan is a 5-HT_1Freceptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. SPARTAN and SAMURAI were double-blind studies of patients with migraine, randomized to oral lasmiditan 50mg (SPARTAN only), 100mg, 200mg, or placebo to be taken within 4 hours of onset of a migraine attack. If needed for rescue/recurrence, a second randomized dose could be taken.

Design/Methods Safety data from SPARTAN and SAMURAI were integrated. Treatment-emergent adverse events (TEAEs) (occurred within 48 hours of first dose, regardless of whether second dose taken) were considered in the analyses.

Results The safety population comprised 1262 participants assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50mg, 100mg, and 200mg, respectively. There were no deaths; serious adverse events were reported for 7 participants (placebo, n=2 [0.2%]; lasmiditan 50mg, n=1 [0.2%]; lasmiditan 100mg, n=1 [0.2%]; lasmiditan 200mg, n=3 [0.2%]). Participants reporting ≥1 TEAE were - Placebo, n=174 (13.5%); lasmiditan 50mg, n=166 (25.4%); lasmiditan 100mg, n=458 (36.2%); and lasmiditan 200mg, n=510 (40.3%). TEAEs were generally mild or moderate in severity. TEAEs in ≥2% of any lasmiditan dose group and more frequent with lasmiditan than placebo (p<0.05) were, in descending order of frequency, dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia; the median times to onset and durations of common TEAEs with lasmiditan were 0.50-0.85 hours and 1.00-4.75 hours, respectively. The frequency of TEAEs were similar in those whose second dose was lasmiditan or placebo. There were no ischemic events. Columbia-Suicide Severity Rating Scale (C-SSRS) reporting of affirmative response(s) was low and similar across treatment groups.

Conclusions

As a centrally-penetrant drug, lasmiditan use was associated with neurologic TEAEs most mild or moderate, of quick onset and self-limiting.

Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174)

Authors/Disclosures
John H. Krege PRESENTER	John H. Krege has received personal compensation for serving as an employee of Eli Lilly. John H. Krege has received stock or an ownership interest from Eli Lilly.
	No disclosure on file
Erin G. Doty, MD (Eli Lilly and Company)	Dr. Doty has received personal compensation for serving as an employee of Eli Lilly and Company, USA. Dr. Doty has stock in Eli Lilly and Company, USA.
	No disclosure on file
Jia Ning Wang	No disclosure on file
Andrew Buchanan	No disclosure on file

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