Partial Epilepsy in Children and Adolescents Clinical Trial
Official title:
Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.
Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many
patients continuing to have symptoms despite trying several medications. Lack of efficacy and
adverse effects are commonly associated with current anti-epileptic drugs.
This study will examine the efficacy in addition to safety and tolerability of a new
anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for
refractory partial seizures in children.
The primary analysis variables are:
- The responder rate (the proportion of patients with at least a 50% reduction in
standardised seizure frequency)
- The relative reduction in standardised seizure frequency
;