EFFECTS OF ESLICARBAZEPINE ACETATE (BIA 2-093) ON COGNITIVE FUNCTION IN CHILDREN WITH PARTIAL ONSET SEIZURES: AN ADD-ON, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE CLINICAL TRIAL

INTERVENTION: Trade Name: Zebinix Product Name: ESLICARBAZEPINE ACETATE Product Code: BIA 2‐093 Pharmaceutical Form: Tablet INN or Proposed INN: Eslicarbazepine Acetate Current Sponsor code: BIA‐2‐093 Other descriptive name: ([S]‐10‐acetoxy‐10,11‐dihydro‐5H‐dibenz[b,f]azepine‐5‐carboxamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1200‐milligram(s) Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial‐onset seizures. ; MedDRA version: 9.1 Level: LLT Classification code 10065336 Term: Partial epilepsy PRIMARY OUTCOME: Main Objective: The primary study objective is to evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial‐onset seizures. Primary end point(s): Change from baseline to the end of the evaluation period in the composite Power of Attention measure in order to assess information processing speed and attention / psychomotor speed. Secondary Objective: • To evaluate the safety and tolerability of ESL in comparison with placebo, over an 8‐week maintenance period preceded by a 4 week titration period and followed by a tapering‐off period. ; • To evaluate the efficacy of ESL compared with placebo as adjunctive therapy in children with refractory partial epilepsy over an 8 week maintenance period. ; • To evaluate the safety, tolerability and sustainability of the therapeutic effect of ESL during a 1‐year open label treatment. ; INCLUSION CRITERIA: At Visit 1 (screening), patient must be / have: 1. Written informed consent signed by parent or legal representative and, where applicable, the patient. 2. Aged 6 to 16 years, inclusive. 3. A documented diagnosis of epilepsy for at least 12 months prior to screening. At least 2 partial onset seizures during the 4 weeks prior to screening despite treatment with 1 to 2 AEDs in a stable dose regimen. 4. An IQ of at least 70. 5. Current treatment with 1 to 2 AEDs (any except oxcarbazepine, benzodiazepines other than clobazam and VNS). 6. Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests. 7. In the opinion of the investigator, able to complete the CDR test battery. 8. In case of a girl of childbearing potential, patient presents a serum ß‐hCG test consistent with a non gravid state and agrees to remain abstinent or use reliable contraception (if used, horm