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ZEBinix® Retention Rate in Epilepsy in Elderly Patients | Clinical Trials | Clareo Health

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ZEBinix® Retention Rate in Epilepsy in Elderly Patients

ZEBinix Retention Rate in Epilepsy in Elderly Patients

NCT04221282•Centre Hospitalier Saint Joseph Saint Luc de Lyon

Summary

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

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.

Eligibility

Age

65 - No limit years

Sex

ALL

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

Locations (1)

Centre Hospitalier St Joseph St Luc

Lyon, France

Key Dates

Start Date

April 1, 2019

Primary Completion Date

September 30, 2020

Completion Date

September 30, 2020

Last Updated

January 9, 2020

Enrollment

ESTIMATED participants

Conditions

EpilepsyAging DisorderAgingEpilepsy; Seizure

Interventions

Zebinix

DRUG

Contacts

Adrien DIDELOT, MD, PhD

CONTACT

0033478616172 adidelot@ch-stjoseph-stluc-lyon.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ZEBinix® Retention Rate in Epilepsy in Elderly Patients

Inclusion Criteria

Exclusion Criteria

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