Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN

John H. Krege, Paul B. Rizzoli, Emily Liffick, Erin G. Doty, Sherie A. Dowsett, Jianing Wang, Andrew S. Buchanan

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: We assessed the safety profile of lasmiditan, a selective 5-HT1F receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. Methods: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. Results: The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. Conclusions: As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).

Original languageEnglish (US)
Pages (from-to)957-966
Number of pages10
JournalCephalalgia
Volume39
Issue number8
DOIs
StatePublished - Jul 1 2019
Externally publishedYes

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Migraine Disorders
Safety
Placebos
Therapeutics
Hypesthesia
Paresthesia
Muscle Weakness
Dizziness
Double-Blind Method
Nausea
Nervous System
Fatigue
Pain
Pharmaceutical Preparations
Population

Keywords

  • Lasmiditan
  • phase 3
  • safety

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine : Results from SAMURAI and SPARTAN. / Krege, John H.; Rizzoli, Paul B.; Liffick, Emily; Doty, Erin G.; Dowsett, Sherie A.; Wang, Jianing; Buchanan, Andrew S.

In: Cephalalgia, Vol. 39, No. 8, 01.07.2019, p. 957-966.

Research output: Contribution to journalArticle

Krege, John H. ; Rizzoli, Paul B. ; Liffick, Emily ; Doty, Erin G. ; Dowsett, Sherie A. ; Wang, Jianing ; Buchanan, Andrew S. / Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine : Results from SAMURAI and SPARTAN. In: Cephalalgia. 2019 ; Vol. 39, No. 8. pp. 957-966.
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abstract = "Background: We assessed the safety profile of lasmiditan, a selective 5-HT1F receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. Methods: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. Results: The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2{\%}]; lasmiditan 50 mg, n = 1 [0.2{\%}]; lasmiditan 100 mg, n = 1 [0.2{\%}]; lasmiditan 200 mg, n = 3 [0.2{\%}]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5{\%}); lasmiditan 50 mg, n = 166 (25.4{\%}); lasmiditan 100 mg, n = 458 (36.2{\%}); and lasmiditan 200 mg, n = 510 (40.6{\%}). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. Conclusions: As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).",
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AU - Doty, Erin G.

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AU - Wang, Jianing

AU - Buchanan, Andrew S.

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AB - Background: We assessed the safety profile of lasmiditan, a selective 5-HT1F receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. Methods: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. Results: The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. Conclusions: As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).

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