ZEBinix® Retention Rate in Epilepsy in Elderly Patients

Centre Hospitalier Saint Joseph Saint Luc de Lyon50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Epilepsy Aging Disorder Aging Epilepsy; Seizure

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 65 years 2. Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion) 3. Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures 4. At least one seizure in the last three months 5. Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy Exclusion Criteria: 1. History of ESL treatment 2. History of status epilepticus, seizures occurring in cluster, pseudo-seizures 3. History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 times ULN, gamma-glutamyltranspeptidase (GGT) \> 5 times ULN) 4. History of severe renal impairment (clearance CLCR \<30ml/min) 5. History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) 6. History of severe hyponatremia (\< 120 mmol/L) 7. Second or third degree atrioventricular block 8. More than one other antiepileptic drug

Outcomes

Primary Outcomes

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.

Time frame: at the end of the study treatment, at 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: through study completion, an average of 6 months

ZEBinix® Retention Rate in Epilepsy in Elderly Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts