Objective:

Evaluate cognitive and behavioral effects of long-term adjunctive brivaracetam (BRV) in children with focal seizures.

Background:

Design/Methods:

Results:

140 patients were included (mean age 9.5 years; 22.9% aged 1.5–5 years [median exposure 3.6 years], 77.1% aged 6–16 years [median exposure 3.5 years]). Mean changes (baseline to last evaluation) for all Achenbach CBCL and BRIEF-P/BRIEF subscale scores were negative, reflecting stability/slight improvement. The largest decreases in CBCL were for aggressive behavior and anxious/depressed (both age groups) and other problems (1.5–5 years). The largest decreases in BRIEF-P/BRIEF scores were for inhibit and working memory (both age groups) and emotional control (2–<5 years). Most patients had no shift in T-score category (baseline to last evaluation) for each CBCL subscale (between normal and borderline clinical range [BCR]) and BRIEF-P/BRIEF subscale (between normal and potential clinical significance [PCS]). For all CBCL subscales, higher proportion of patients changed from BCR to normal than from normal to BCR. Changes for BRIEF-P were mostly PCS to normal; for BRIEF, similar proportions of patients changed in either direction. Treatment-emergent adverse events (TEAEs) were reported in 100% and 95.4% of patients aged 1.5–5 and 6–16 years (drug-related TEAEs 31.3%, 30.6%; discontinuations due to TEAEs 6.3%, 9.3%).

Conclusions:

Cognitive and behavioral functioning scores in children and adolescents with focal seizures during long-term adjunctive BRV therapy were generally stable or slightly improved. BRV was generally well tolerated.