Characterization of Dizziness After Lasmiditan Usage

Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials

Stewart J. Tepper, John H. Krege, Louise Lombard, Josephine K. Asafu-Adjei, Sherie A. Dowsett, Joel Raskin, Andrew S. Buchanan, Deborah I Friedman

Research output: Contribution to journalArticle

Abstract

Trial Design: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. Methods: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. Results: Dizziness incidence was as follows: Placebo (N = 1262), 2.9% (0.1% severe); lasmiditan 50 mg (N = 654), 8.6% (0.3% severe); lasmiditan 100 mg (N = 1265), 14.9% (0.7% severe); and lasmiditan 200 mg (N = 1258), 16.8% (1.4% severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3%); 100 mg, n = 11 (0.9%); 200 mg, n = 7 (0.6%); and placebo, n = 1 (<0.1%). Conclusion: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.

Original languageEnglish (US)
Pages (from-to)1052-1062
Number of pages11
JournalHeadache
Volume59
Issue number7
DOIs
StatePublished - Jul 1 2019

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Dizziness
Migraine Disorders
Placebos
Therapeutics
Pain
Vertigo
Incidence
Hispanic Americans
Pharmaceutical Preparations
Germany
Body Mass Index

Keywords

  • clinical trial
  • dizziness
  • lasmiditan
  • vertigo

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Characterization of Dizziness After Lasmiditan Usage : Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials. / Tepper, Stewart J.; Krege, John H.; Lombard, Louise; Asafu-Adjei, Josephine K.; Dowsett, Sherie A.; Raskin, Joel; Buchanan, Andrew S.; Friedman, Deborah I.

In: Headache, Vol. 59, No. 7, 01.07.2019, p. 1052-1062.

Research output: Contribution to journalArticle

Tepper, SJ, Krege, JH, Lombard, L, Asafu-Adjei, JK, Dowsett, SA, Raskin, J, Buchanan, AS & Friedman, DI 2019, 'Characterization of Dizziness After Lasmiditan Usage: Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials', Headache, vol. 59, no. 7, pp. 1052-1062. https://doi.org/10.1111/head.13544
Tepper, Stewart J. ; Krege, John H. ; Lombard, Louise ; Asafu-Adjei, Josephine K. ; Dowsett, Sherie A. ; Raskin, Joel ; Buchanan, Andrew S. ; Friedman, Deborah I. / Characterization of Dizziness After Lasmiditan Usage : Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials. In: Headache. 2019 ; Vol. 59, No. 7. pp. 1052-1062.
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title = "Characterization of Dizziness After Lasmiditan Usage: Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials",
abstract = "Trial Design: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. Methods: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. Results: Dizziness incidence was as follows: Placebo (N = 1262), 2.9{\%} (0.1{\%} severe); lasmiditan 50 mg (N = 654), 8.6{\%} (0.3{\%} severe); lasmiditan 100 mg (N = 1265), 14.9{\%} (0.7{\%} severe); and lasmiditan 200 mg (N = 1258), 16.8{\%} (1.4{\%} severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3{\%}); 100 mg, n = 11 (0.9{\%}); 200 mg, n = 7 (0.6{\%}); and placebo, n = 1 (<0.1{\%}). Conclusion: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.",
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author = "Tepper, {Stewart J.} and Krege, {John H.} and Louise Lombard and Asafu-Adjei, {Josephine K.} and Dowsett, {Sherie A.} and Joel Raskin and Buchanan, {Andrew S.} and Friedman, {Deborah I}",
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T2 - Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials

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AU - Krege, John H.

AU - Lombard, Louise

AU - Asafu-Adjei, Josephine K.

AU - Dowsett, Sherie A.

AU - Raskin, Joel

AU - Buchanan, Andrew S.

AU - Friedman, Deborah I

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N2 - Trial Design: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. Methods: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. Results: Dizziness incidence was as follows: Placebo (N = 1262), 2.9% (0.1% severe); lasmiditan 50 mg (N = 654), 8.6% (0.3% severe); lasmiditan 100 mg (N = 1265), 14.9% (0.7% severe); and lasmiditan 200 mg (N = 1258), 16.8% (1.4% severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3%); 100 mg, n = 11 (0.9%); 200 mg, n = 7 (0.6%); and placebo, n = 1 (<0.1%). Conclusion: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.

AB - Trial Design: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. Methods: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. Results: Dizziness incidence was as follows: Placebo (N = 1262), 2.9% (0.1% severe); lasmiditan 50 mg (N = 654), 8.6% (0.3% severe); lasmiditan 100 mg (N = 1265), 14.9% (0.7% severe); and lasmiditan 200 mg (N = 1258), 16.8% (1.4% severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3%); 100 mg, n = 11 (0.9%); 200 mg, n = 7 (0.6%); and placebo, n = 1 (<0.1%). Conclusion: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.

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