Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures

This is an interventional treatment trial for Partial Epilepsy focused on measuring Partial Epilepsy, eslicarbazepine acetate, Children Read More

Inclusion Criteria:

At visit 1 (screening), patient must be/have:

• written informed consent by parent or legal guardian and, where applicable, the patient;
• age 6 to 16 years, inclusive;
• 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;
• an Intelligence Quotient (IQ) of at least 70;
• current treatment with 1 to 2 AEDs (except oxcarbazepine, benzodiazepines other than clobazam and vagus nerve stimulation (VNS));
• excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and clinical laboratory tests;
• in the opinion of the investigator, able to complete the Cognitive Drug Research (CDR) test battery;
• in case of a girl of childbearing potential, patient presents a serum B-human chorionic gonadotropin (B hCG) test consistent with a non gravid state and agrees to remain abstinent or use reliable contraception (if used, hormonal contraception must be combined with a barrier method) starting at screening and continuing until at least the post-study visit (PSV).

At visit 2 (randomisation), patient must be/have:

• at least 2 partial-onset seizures during the 4 week baseline period prior to randomisation (documented in a diary);
• in case of a girl of childbearing potential, patient presents a urine B-hCG test consistent with a non-gravid state;
• stable dose regimen of concomitant AEDs during the 4 week baseline period;
• diaries satisfactorily completed by the patient or his/her caregiver during the baseline period;
• satisfactory compliance with the study requirements during the baseline period.

Exclusion Criteria:

At visit 1 (screening), patients must not be/have:

• only simple partial seizures with no motor symptomatology;
• primarily generalised seizures;
• known rapidly progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion);
• occurrence of seizures too close to count accurately;
• history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening; seizures of non-epileptic origin;
• Lennox-Gastaut syndrome;
• West syndrome;
• major psychiatric disorders;
• seizures of psychogenic origin within the last 2 years;
• history of schizophrenia or suicide attempt;
• history of attention deficit disorder or other diseases adversely affecting cognitive abilities;
• currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a routine or chronic basis) and/or VNS;
• known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine);
• uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder;
• second or third degree atrioventricular blockade;
• relevant clinical laboratory abnormalities;
• estimated creatinine clearance (CLCR) <60 mL/min;
• pregnancy or nursing;
• treatment with eslicarbazepine acetate in any previous study;
• participation in other drug clinical trial within the last 2 months;
• not ensured capability to perform the trial;
• any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.

At visit 2 (randomisation), patients must not be / have:

• any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.