Informations générales (source: ClinicalTrials.gov)
ZEBinix Retention Rate in Epilepsy in Elderly Patients (ZEBRE)
Observational
Centre Hospitalier Saint Joseph Saint Luc de Lyon (Voir sur ClinicalTrials)
avril 2019
septembre 2020
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier St Joseph St Luc - 69007 - Lyon - France | Adrien DIDELOT, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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