Conditions: Partial Epilepsy in Children and Adolescents
Keywords: Epilepsy Partial Refractory Children Adolescents Adjunctive Randomised Double-blind Placebo-controlled Parallel-group
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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

Arms:
arm 1: To receive Eslicarbazepine acetate in addition to concomitant therapy arm 2: To receive placebo in addition to concomitant therapy

Interventions: intervention 1: Eslicarbazepine acetate (BIA 2-093) intervention 2: Eslicarbazepine acetate
Intervention descriptions: intervention 1: Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.

The recommended target dose of double-blind study treatment will be 20mg/kg/day.

Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year. intervention 2: Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.

Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.

Protocol document: