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-HT_1F 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-e

SUBMITTER: Tassorelli C 

PROVIDER: S-EPMC8572440 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature