ZEBinix® Retention Rate in Epilepsy in Elderly Patients (ZEBRE)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status: Unknown

Conditions: Aging Disorder; Aging; Epilepsy; Epilepsy; Seizure

Treatments: Drug: Zebinix

Study type: Observational

Funder types: Other

Identifiers

NCT04221282

ZEBRE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Epileptic elderly patients

Description:

Elderly patients with partial-onset seizures

Treatment:

Drug: Zebinix