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

Exclusion Criteria

• •1. Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
• •2. Primarily generalised seizures;
• •3. Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
• •4. Occurrence of seizures too close to count accurately;
• •5. History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
• •6. Seizures of non-epileptic origin;
• •7. Major psychiatric disorders;
• •8. History of suicide attempt;
• •9. Currently treated with oxcarbazepine;
• •10. Previous use of ESL or participation in a clinical study with ESL;
• •11. Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
• •12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
• •13. Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
• •14. 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;
• •15. Calculated creatinine values \< 30 mL/min at screening;
• •16. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
• •17. 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.