Eslicarbazepine Acetate Associated with Reduced Seizure Severity in Addition to Reduced Seizure Frequency (P2.031)

OBJECTIVE: To examine the effect of adjunctive eslicarbazepine acetate (ESL) on seizure severity and bothersomeness. BACKGROUND: In a phase III, randomized, double-blind trial (093-304), patients with refractory partial-onset seizures, treated with adjunct ESL (800 mg or 1200 mg QD), had significantly greater seizure frequency reduction than placebo-treated patients. The Seizure Severity Questionnaire (SSQ), a multi-dimensional patient-reported assessment designed for use in clinical research, was administered at baseline and week 14 (2-week titration, 12-week maintenance) in the three treatment arms. METHODS: The SSQ total score (TS) and domain scores (frequency and helpfulness of warning signs before seizures [BS], severity and bothersomeness of ictal movement and altered consciousness during seizures [DS], cognitive, emotional, and physical aspects of postictal recovery after seizures [AS], and overall severity and bothersomeness [SB]) were calculated for the per-protocol population (n=547). Analysis of covariance models, adjusted for baseline SSQ scores, estimated least square means (LSMs) at week 14 for each arm. LSM differences between the three arms were compared to established minimal clinically-important differences (MCIDs). RESULTS: Overall, 441 (81.1[percnt]) patients had a valid SSQ TS at baseline and week 14. Week 14 LSM TS was significantly lower for ESL 1,200 mg than placebo (2.68 vs 3.20, p p =0.027), AS (1.95 vs. 2.51, p=0.019), and SB (3.09 vs. 3.65, p p =0.013). CONCLUSIONS: In this post hoc analysis, ESL-treated patients had significantly less seizure severity and bothersomeness than placebo patients. Disclosure: Dr. Cramer has received personal compensation for activities with Bial, Eisai Inc., Sepracor, UCB Pharma, and Sunovion as a consultant. Dr. Velez has received personal compensation for activities with Sunovion as an employee. Dr. Anastassopoulos has received personal compensation for activities with Covance as an employee. Dr. Bond has nothing to disclose. Dr. Wang has received personal compensation for activities with Covance as an employee. Dr. Blum has received personal compensation for activities with Sunovion Pharmaceuticals Inc. as an employee. Dr. Moreira has received personal compensation for activities with BIAL. Dr. Rocha has received personal compensation for activities with Bial as an employee.