Abstracts

Rationale: To assess the improvement in quality-of-life and depressive symptoms during long-term adjunctive therapy with eslicarbazepine acetate (ESL) in patients with refractory partial epilepsy. Methods: During an open-label extension of a phase 3 study (BIA-2093-302) with ESL, the Quality-of-Life in Epilepsy Inventory 31 (QOLIE-31) and Montgomery Asberg Depression Rating Scale (MADRS) were applied at the end of the treatment period (1 year or early discontinuation) and the results were compared with those at baseline. Most patients were treated with ESL 800 mg once-daily (range: 400-1200 mg). Results: The QOLIE-31 results in the intent-to-treat (ITT) population (n=255) demonstrated significant improvements from baseline in overall quality-of-life (p<0.001), seizure worry (p<0.0001), medication effects (p<0.05), and the overall score (p<0.05) (Figure 1). In the per-protocol (PP) population (n=102), significant improvements were found in overall quality-of-life (p<0.05), seizure worry (p<0.05), emotional well-being (p<0.05), energy-fatigue (p<0.05), and overall score (p<0.01). When assessing the MADRS results in the ITT population (n=271), statistically significant improvements were found in the total score (from 8.2 to 6.5; p<0.0001), apparent sadness (p<0.001), inner tension (p<0.05), reported sadness (p<0.05), reduced sleep (p<0.001), inability to feel (p<0.01), and pessimistic thoughts (p<0.001) (Figure 2). In the PP population (n=109), significant improvements were found in the total score (p<0.01), apparent sadness (p<0.01), reported sadness (p<0.05), reduced sleep (p<0.05), inability to feel (p<0.01), and suicidal thoughts (p<0.05). Conclusions: During long-term open-label adjunctive therapy in partial epilepsy, ESL demonstrated statistically and clinically significant improvements in quality-of-life, as assessed by QOLIE-31, and depressive mood, as assessed by MADRS. Supported by BIAL- Portela & Co, SA