None listed
Conditions
Interventions
Drug : Eslicarbazepine (400, 800, 1200 mg)should be taken orally once-daily.
Sponsors
Pharmanet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit 1 (Screening), patient must be/have 1. writtem informed consent; 2. of age 65 years or older; 3. a documented diagnosis of epilepsy for at least 12 months; 4. at least 1 partial-onset seizure (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised)in the 4 weeks prior to Screening; 5. 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); 6. willing and able to comply with all trial requirements, in the judgement of the investigator. At Visit 2 (start of ESL treatment), patient must have; 7. at least 2 partial-onset seizures (documented in the diary) during the 8-week baseline period. 8. satisfactorily complied with the study requirements during the baseline period.
Exclusion criteria
Exclusion criteria: 1. only simple partial seizures with no motor symptomatology (classifided 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 epilepticus or cluster seizures (i.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 (ECGT) as determined by the investigator; 14. relevant clinical laboratory abnormalities as determined by the investigator(e.g.,plasmasodium2.0 times above the upper limit of the normal range, or white blood cell count<3,000 cells/mm 15. calculated creatinine clearance values < 30mL/min at screening; 16. any other condition or circumstance that, in the opinion of the investigator, may compromise the patients'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. 18. positive for HLS-B*1502 (patients form Asian countries only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety : Adverse Events, Clinical laboratory evaluations, Vital sign, Physical and neurological examinations, 12-lead ECG, Scales for evaluating sedative effects, C-SSRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : Seizures frequency, MMSE, QOLIE-31, PGIC | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Bong Hong
Samsung Medical Center
Outcome results
None listed