Post Hoc Analysis Examines Eslicarbazepine Acetate and Seizure Severity Findings
VANCOUVER, BC—Adjunctive eslicarbazepine acetate (ESL) reduces seizure severity in patients with refractory partial-onset seizures (POS), suggests an analysis of Phase 3 clinical trial data reported in a poster presentation at the 68th AAN Annual Meeting.
“In this post-hoc analysis, approved therapeutic doses of ESL led to dose-dependent reductions in seizure severity, as indicated by SSQ [Seizure Severity Questionnaire] scores,” wrote Joyce A. Cramer, MD, of Yale University, and her coauthors.
A total of 547 patients in a Phase 3, randomized, double-blind trial (093-304) completed the Seizure Severity Questionnaires (SSQ) at baseline and after Week 14 of taking ESL (800mg or 1200mg once daily).
The trial was not powered for detecting differences in the secondary endpoints included in the post-hoc analysis, the researchers cautioned.
SSQ scores analyzed included total score (TS), after-seizure (AS) scores of cognitive, emotional, and physical post-ictal recovery, and overall severity and bother (SB, a measure of seizures' “general impact”).
“The Week 14 SSQ scores for TS, AS, and SB were significantly lower in the ESL 1200mg QD [once-daily] arm than in the placebo arm and exceeded the threshold for clinically-meaningful change,” they reported. At Week 14, the estimated least-squares mean (LSM) TS was 2.68 for the ESL group compared to 3.20 for the placebo group (P<0.001). This provides a difference of 0.52 which exceeds the minimal clinically-important differences score of 0.48, they reported.