Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine

Abstract Background Lasmiditan (LTN) is a selective 5-HT1F receptor agonist for the acute treatment of migraine in adults. We present detailed safety findings from the placebo-controlled, double-blind Phase 3 study, of LTN treatment across 4 attacks (CENTURION). Methods Patients were randomized 1:1:...

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Autores principales:	C Tassorelli, S Bragg, JH Krege, EG Doty, PA Ardayfio, D Ruff, SA Dowsett, T Schwedt
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Lasmiditan Clinical trial Migraine Safety Adverse events Multiple attacks Medicine R
Acceso en línea:	https://doaj.org/article/55ad02cbed234cf4a58c92860dd14765
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spelling	oai:doaj.org-article:55ad02cbed234cf4a58c92860dd147652021-11-08T11:13:31ZSafety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine10.1186/s10194-021-01343-21129-23691129-2377https://doaj.org/article/55ad02cbed234cf4a58c92860dd147652021-11-01T00:00:00Zhttps://doi.org/10.1186/s10194-021-01343-2https://doaj.org/toc/1129-2369https://doaj.org/toc/1129-2377Abstract Background Lasmiditan (LTN) is a selective 5-HT1F receptor agonist for the acute treatment of migraine in adults. We present detailed safety findings from the placebo-controlled, double-blind Phase 3 study, of LTN treatment across 4 attacks (CENTURION). Methods Patients were randomized 1:1:1 to LTN 200 mg (LTN200), LTN100, or a control group that received placebo for 3 attacks and LTN50 for either the 3rd or 4th attack (1:1). Safety analyses were conducted for patients who took ≥1 dose of study drug and, in some cases, those who took all 4 doses. Results Overall, 1471 patients treated 4494 attacks. The incidences of treatment-emergent serious adverse events (SAEs) were - placebo, n=2 (0.4 %); LTN100, n=1 (0.2 %); LTN200, n=2 (0.4 %); no specific treatment-emergent SAE was reported in more than one patient. The most common treatment emergent adverse events (TEAEs) with lasmiditan were dizziness, paresthesia, fatigue, nausea, vertigo, and somnolence; the vast majority were mild or moderate in severity. The incidences of these TEAEs were highest during the first attack and decreased during subsequent attacks. For patients who experienced a common TEAE with the first attack, less than 45 % experienced the same event in subsequent attacks. Patients who did not experience an event in the 1st attack infrequently experienced the same event in subsequent attacks. The time of onset of the common TEAE ranged from ~40 min to 1 h (dependent upon TEAE) and, for individual TEAE, the onset was similar across attacks. Duration was dependent upon TEAE and attack. It was shortest for paresthesia (< 2 h for all attacks); it ranged from 1.8 to 5.5 h for other common TEAEs and was generally similar across attacks. Serotonin syndrome was reported for 2 patients post LTN dosing; there were no meaningful differences across treatment groups in suicidality; there was no evidence of an increase in motor vehicle accidents. Conclusion In this blinded, controlled, multiple-attack study, LTN was associated with generally mild or moderate CNS-related TEAEs of short duration. TEAEs tended to decrease in frequency across the 4 attacks. Trial registration NCT03670810C TassorelliS BraggJH KregeEG DotyPA ArdayfioD RuffSA DowsettT SchwedtBMCarticleLasmiditanClinical trialMigraineSafetyAdverse eventsMultiple attacksMedicineRENThe Journal of Headache and Pain, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Lasmiditan Clinical trial Migraine Safety Adverse events Multiple attacks Medicine R
spellingShingle	Lasmiditan Clinical trial Migraine Safety Adverse events Multiple attacks Medicine R C Tassorelli S Bragg JH Krege EG Doty PA Ardayfio D Ruff SA Dowsett T Schwedt Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
description	Abstract Background Lasmiditan (LTN) is a selective 5-HT1F receptor agonist for the acute treatment of migraine in adults. We present detailed safety findings from the placebo-controlled, double-blind Phase 3 study, of LTN treatment across 4 attacks (CENTURION). Methods Patients were randomized 1:1:1 to LTN 200 mg (LTN200), LTN100, or a control group that received placebo for 3 attacks and LTN50 for either the 3rd or 4th attack (1:1). Safety analyses were conducted for patients who took ≥1 dose of study drug and, in some cases, those who took all 4 doses. Results Overall, 1471 patients treated 4494 attacks. The incidences of treatment-emergent serious adverse events (SAEs) were - placebo, n=2 (0.4 %); LTN100, n=1 (0.2 %); LTN200, n=2 (0.4 %); no specific treatment-emergent SAE was reported in more than one patient. The most common treatment emergent adverse events (TEAEs) with lasmiditan were dizziness, paresthesia, fatigue, nausea, vertigo, and somnolence; the vast majority were mild or moderate in severity. The incidences of these TEAEs were highest during the first attack and decreased during subsequent attacks. For patients who experienced a common TEAE with the first attack, less than 45 % experienced the same event in subsequent attacks. Patients who did not experience an event in the 1st attack infrequently experienced the same event in subsequent attacks. The time of onset of the common TEAE ranged from ~40 min to 1 h (dependent upon TEAE) and, for individual TEAE, the onset was similar across attacks. Duration was dependent upon TEAE and attack. It was shortest for paresthesia (< 2 h for all attacks); it ranged from 1.8 to 5.5 h for other common TEAEs and was generally similar across attacks. Serotonin syndrome was reported for 2 patients post LTN dosing; there were no meaningful differences across treatment groups in suicidality; there was no evidence of an increase in motor vehicle accidents. Conclusion In this blinded, controlled, multiple-attack study, LTN was associated with generally mild or moderate CNS-related TEAEs of short duration. TEAEs tended to decrease in frequency across the 4 attacks. Trial registration NCT03670810
format	article
author	C Tassorelli S Bragg JH Krege EG Doty PA Ardayfio D Ruff SA Dowsett T Schwedt
author_facet	C Tassorelli S Bragg JH Krege EG Doty PA Ardayfio D Ruff SA Dowsett T Schwedt
author_sort	C Tassorelli
title	Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
title_short	Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
title_full	Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
title_fullStr	Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
title_full_unstemmed	Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
title_sort	safety findings from centurion, a phase 3 consistency study of lasmiditan for the acute treatment of migraine
publisher	BMC
publishDate	2021
url	https://doaj.org/article/55ad02cbed234cf4a58c92860dd14765
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Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine

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