Safety and efficacy of ESLICARBAZEPINE ACETATE (ESL) as an additional anti-epileptic drug for elderly patients suffering from partial seizures of epilepsy

Conditions: Adjunctive therapy of partial-onset seizures in elderly patients
MedDRA version: 14.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2009-012587-14-CZ

Lead Sponsor: BIAL - Portela & Ca, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the safety and tolerability of ESL as adjunctive therapy in patients aged =65 years with partial epilepsy, over a 26-week Treatment Period.;Secondary Objective: The secondary objective of this study is to explore the efficacy of ESL as adjunctive therapy in patients aged =65 years with partial epilepsy, over a 26-week Treatment Period.;Primary end point(s): The primary endpoint is safety assessed by incidence of adverse events, clinical laboratory safety tests, ECG, blood pressure and heart rate.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy parameters are evaluated as secondary endpoints.<br><br>

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