Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.

Inclusion criteria

• Written informed consent form;
• Of age 65 years or older;
• A documented diagnosis of epilepsy for at least 12 months,
• At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
• Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
• Willing and able to comply with all trial requirements, in the judgment of the investigator;
• At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
• Satisfactorily complied with the study requirements during the baseline period

Exclusion criteria

• Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
• Primarily generalised seizures;
• Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
• Occurrence of seizures too close to count accurately;
• History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
• Seizures of non-epileptic origin;
• Major psychiatric disorders;
• History of suicide attempt;
• Currently treated with oxcarbazepine;
• Previous use of ESL or participation in a clinical study with ESL;
• Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
• Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
• Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
• Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3;
• Calculated creatinine values < 30 mL/min at screening;
• Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
• Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.