Data presented at 12th European Congress on Epileptology (ECE) offers new insights into seizure control and safety profile of eslicarbazepine acetate in the treatment of newly diagnosed partial onset (focal) seizures in adults
Methodology also announced for large pan-European pooled analyses of eslicarbazepine acetate real-world data to assess use for partial epilepsy in clinical practice
Porto, Portugal | Hatfield, UK | 13 September 2016 – Data from an investigational Phase III study for adjunctive eslicarbazepine acetate in a monotherapy setting showed that eslicarbazepine acetate is non-inferior to controlled release (CR) carbamazepine in patients with newly diagnosed partial onset seizures. Eslicarbazepine acetate is currently indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.
The non-inferiority study included 785 eligible patients (≥18 years) with newly diagnosed partial-onset seizures, who were randomised to receive eslicarbazepine acetate or carbamazepine CR in a three-step dose-level design. Dose-levels were maintained through a 26-week evaluation period and subjects who remained seizure-free at any dose level continued through subsequent phases of the study. The primary endpoint for the study was the proportion of patients with 26-week seizure freedom (non-inferiority difference margin of -12%) in the per-protocol (PP) population.