Abstract Details

Title Cognitive and Behavioral Effects of Adjunctive Brivaracetam in Children and Adolescents with Focal Seizures: Final Data From an Open-label Follow-up Trial

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-007

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

Background

Children with epilepsy are at increased risk for cognitive and behavioral problems.

Design/Methods Post-hoc analysis of phase 3, open-label, follow-up trial (N01266; NCT01364597; patients <16 years at core trial entry; ≤5 mg/kg/day BRV tablet/oral solution [≤200 mg/day]). Planned trial duration ≥3 years. Outcomes included Achenbach Child Behavior Checklist (CBCL; ages 1.5–5 and 6–18 years), Behavior Rating Inventory of Executive Function (BRIEF; ages 2–<5 [BRIEF-P] and 5–16 years).

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.

Authors/Disclosures
Frank Tennigkeit, PhD (UCB Biosciences GmbH) PRESENTER	Dr. Tennigkeit has received personal compensation for serving as an employee of UCB Biosciences. Dr. Tennigkeit has stock in UCB Biosciences.
Jan-Peer Elshoff, PhD (Schwarz Biosciences GmbH)	Dr. Elshoff has nothing to disclose.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Florin Floricel (UCB Biosciences GmbH)	No disclosure on file
	No disclosure on file

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