ZEBinix® Retention Rate in Epilepsy in Elderly Patients

Study Overview
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Brief Summary
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The incidence of provoked and unprovoked seizures is known to increase with advancing age. Eslicarbazepine acetate (ESL) is one of the third generation of antiepileptic drugs (AEDs) that have been developed in the last ten years with a favorable safety profile. ESL is approved in Europe and the USA as adjunctive or monotherapy in adults with partial-onset seizures. Nevertheless, retrospective data in monotherapy condition in the elderly epileptic population are sparse. The aim of the ZEBRE study is to evaluate the efficacy and the safety of ESL in elderly epileptic patients (> 65 years). The completion of this study will provide crucial information on the most appropriate ESL treatment for elderly patients suffering from partial seizures.

Detailed Description
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The ZEBRE (ZEBinix® Retention rate in epilepsy in Elderly patients) study is a prospective, multicenter, descriptive study. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics.

Official Title
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ZEBinix Retention Rate in Epilepsy in Elderly Patients

Conditions
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Epilepsy, Aging Disorder, Aging, Epilepsy; Seizure

Intervention / Treatment
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* Drug: Zebinix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 years Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion) Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures At least one seizure in the last three months Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy Exclusion Criteria: History of ESL treatment History of status epilepticus, seizures occurring in cluster, pseudo-seizures History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 times ULN, gamma-glutamyltranspeptidase (GGT) > 5 times ULN) History of severe renal impairment (clearance CLCR <30ml/min) History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) History of severe hyponatremia (< 120 mmol/L) Second or third degree atrioventricular block More than one other antiepileptic drug

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epileptic elderly patients<br>Elderly patients with partial-onset seizures | Drug: Zebinix<br>* ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected.<br>* Other names: Eslicarbazepine acetate (ESL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate of ESL treatment as assessed by the number of patients that are still included in the study. | The retention rate is representative of the effect of ESL since ESL will be pursued only if ESL has a sufficient efficacy without adverse effect. To evaluate the effect of ESL in elderly patients with partial-onset seizures, the retention rate will be measured after 6 months of treatment with ESL. | at the end of the study treatment, at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients as assessed by QOLIE-10 questionnaire | QOLIE-10 (quality of life in epilepsy) is a quality of life questionnaire for adults with epilepsy. There are 10 questions about health and daily activities. All positive responses are lower numbers and all negative responses are higher numbers. | at each visits required by the study (baseline, 3 months and 6 months) | 
| Quality of life of patients as assessed by QoL-AD questionnaire | Some patients with epilepsy also have cognitive decline. QOL-AD (quality of life in Alzheimer'disease) measure quality of life in people with severe cognitive decline. A total score of 13-52, with higher scores indicating better QoL. | at each visits required by the study (baseline, 3 months and 6 months) | 
| Quality of life of patients as assessed by NDDIE questionnaire | NDDI-E (neurological disorder depression inventory for epilepsy) is used for detecting major depressive disorder; a total score above 15 should raise the suspicion of a major depressive episode. | at each visits required by the study (baseline, 3 months and 6 months) | 
| Incidence of treatment- adverse events as assessed by adverse events reports | Number of patients with treatment-related adverse events will be reported to the pharmacovigilance department. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment will be assessed. | through study completion, an average of 6 months | 
| Incidence of seizures as assessed by the occurrence of seizures | The number and the type of seizures or the number of seizure free in elderly patients will be reported | at each visits required by the study (baseline, 3 months and 6 months) | 
| Observance of the treatment as recorded by the control of the drug administration | The treatment delivery by the pharmacy be performed to assess the compliance of the treatment. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, elderly, aging, zebinix, Eslicarbazepine acetate, tolerance, antiepileptic drug