Abstract Details

Title Cognitive and Behavioral Effects and Tolerability of Adjunctive Brivaracetam in Children and Adolescents with Focal Seizures: Pooled Interim Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P13 - Poster Session 13 (8:00 AM-9:00 AM)

Poster/Presentation
Number 10-004

Background

Children with epilepsy have higher incidences of cognitive/behavioral issues than those without.

Objective To evaluate cognitive/behavioral effects and tolerability of long-term adjunctive brivaracetam (BRV) in children/adolescents with focal seizures.

Design/Methods Interim post-hoc analysis (cutoff 14Jul2020) of pooled data from Phase IIa, open-label trial (N01263/NCT00422422; patients aged ≥1 month–<16 years) and ongoing, Phase III, open-label, long-term follow-up (N01266/NCT01364597; direct enrollers aged ≥4–<17 years). Cognitive/behavioral outcomes were assessed with Achenbach CBCL (1.5–5/6–16 years) and BRIEF-P/BRIEF (<5/5–16 years).

Results 140 patients were analyzed (mean age: 9.5 years; 57.1% male). Mean changes from baseline to final visit (raw subscale scores): CBCL 1.5–5 aggressive behavior/anxious&depressed/attention problems/emotionally reactive/sleep problems/somatic complaints/withdrawn/other problems: -1.4/-1.5/-0.5/-1.0/-1.1/-0.9/-0.7/-3.2; CBCL 6–18 aggressive behavior/anxious&depressed/attention problems/rule-breaking behavior/social problems/somatic complaints/thought problems/withdrawn&depressed: -1.8/-1.4/-1.2/-0.7/-0.5/-1.2/-0.8/-0.1; BRIEF-P inhibit/shift/emotional control/working memory/plan&organize: -6.6/-2.1/-4.9/-4.0/-3.0; BRIEF inhibit/shift/emotional control/initiate/working memory/plan&organize/organization of materials/monitor: -1.6/-0.5/-1.0/-0.6/-1.8/-1.4/-0.8/-0.9. Most patients in both age groups had no shift in T-score category from baseline to last evaluation for each CBCL subscale (between normal and borderline or clinical range [BCR]) and BRIEF-P/BRIEF subscale (between normal and potential clinical significance [PCS]). For all CBCL subscales, more patients changed from BCR to normal (1.5–5/6–18: range 6.2–21.9%/12.7–18.6%) than normal to BCR (3.1–9.4%/2.9–13.7%). Changes across BRIEF-P subscales were mostly from PCS to normal (range 14.3–28.6%; 1 patient [14.3%] changed from normal to PCS in one subscale). Across BRIEF subscales, similar proportions of patients changed from normal to PCS (range 6.9–16.8%) and PCS to normal (6.9–12.9%). Incidences of treatment-emergent adverse events (TEAEs): overall (1.5–5/6–16 years: 100%/95.4%); drug-related (40.6%/34.3%); serious (18.8%/26.9%); discontinuations due to TEAEs (6.3%/7.4%); deaths (3.1% [n=1]/0.9% [n=1]).

Conclusions In this pooled interim analysis, cognitive/behavioral functioning scores in children and adolescents with focal seizures under long-term adjunctive BRV were generally stable or slightly improved as compared with baseline. BRV was generally well tolerated.

Authors/Disclosures
Jan-Peer Elshoff, PhD (Schwarz Biosciences GmbH) PRESENTER	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