Project title

Eslicarbazepine acetate - Epilepsy treatment in pediatric patients

Scientific Coordinator's name:

Prof. Patrício Soares-da-Silva

Scientific Coordinator's e-mail:

psoares.silva@bial.com

Principal R&D Unit:

Prof. Patrício Soares-da-Silva

Other R&D Units involved in the project:

Other R&D units involved in the project

Project keyword(s)

Eslicarbazepine acetate, Epilepsy, Pediatric, Adjunctive therapy

Short abstract and comments

BIAL – Portela & Cª, S.A. is performing a confirmatory phase III study to assess the efficacy and safety of eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial epilepsy. As cognitive co-morbidity is of particular concern in children with epilepsy, due to the impact on learning and psychosocial interaction, a second pediatric study is being conducted in children and adolescents with refractory partial-onset seizures to assess the cognitive effects and safety of adjunctive eslicarbazepine acetate. Cognitive effects will be assessed using the UBC System, a validated cognitive test battery, and will be related to the developmental changes and disease progression occurring in the study population.

Potential uses/indications

Adjunctive therapy in pediatric patients