Abstract

Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration.Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (=16?years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200?mg/day (without titration) vs. placebo during a 12-week treatment period.A total of 1262 patients received the following: placebo (n?=?459), BRV 50?mg/day (n?=?200), BRV 100?mg/day (n?=?353), and BRV 200?mg/day (n?=?250). Both the incidence (p?

View details for DOI 10.1016/j.yebeh.2020.107212

View details for PubMedID 32544700