To assess change from baseline in cognition (EpiTrack^®) scores, efficacy, and safety in a subgroup of patients with a history of psychiatric and behavioral events from the Phase IV ELEVATE Study (Study 410; NCT03288129).

ELEVATE assessed perampanel monotherapy/first adjunctive therapy in patients aged ≥4 years with focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS).

In the Safety Analysis Set, 54 patients received perampanel monotherapy/first adjunctive therapy. Of those, 24 patients (FOS, n=17; FBTCS, n=2; GTCS, n=4) had a history of psychiatric and behavioral events and were included in this post hoc analysis. The mean (standard deviation) changes from baseline in EpiTrack^® total score at 12 months and end of treatment were -1.1 (3.14; n=11) and -0.5 (2.61; n=23), respectively (increase=improvement). Median percent reduction in seizure frequency/28 days during the entire Maintenance Period was 73.2% (n=22). The incidence of any treatment-emergent adverse events (TEAEs) in this subgroup was 95.8% (n=23/24). The most common TEAEs were dizziness (25.0%, n=6/24) and vomiting (20.8%, n=5/24).