EUCTR2009-012587-14-CZActive, not recruitingNot Applicable
SAFETY AND EFFICACY OF ESLICARBAZEPINE ACETATE (ESL) AS ADJUNCTIVE THERAPY FOR PARTIAL SEIZURES IN ELDERLY PATIENTS
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- BIAL - Portela & Ca, S.A.
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria at Screening (V1).
- •Patient must be /have:
- •1) written 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
- •At Visit 1 (Screening), patients must not be / have:
- •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 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 (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 normal range, or white blood cell count <3,000 cells/mm3);
- •15. calculated creatinine clearance 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.
Investigators
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