Safety and efficacy of eslicarbazepine acetate (ESL) as adjunctive for partial seizures in elderly patients
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0000512
- Lead Sponsor
- Pharmanet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
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.
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.,plasmasodium<130 mmol/L, alanine or aspartate aminotransferases>2.0 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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety : Adverse Events, Clinical laboratory evaluations, Vital sign, Physical and neurological examinations, 12-lead ECG, Scales for evaluating sedative effects, C-SSRS
- Secondary Outcome Measures
Name Time Method Efficacy : Seizures frequency, MMSE, QOLIE-31, PGIC