ZEBinix® Retention Rate in Epilepsy in Elderly Patients

• Conditions: Epilepsy; Aging Disorder; Aging; Epilepsy; Seizure
• Interventions: Drug: Zebinix

• Registration Number: NCT04221282
• Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Brief 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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-11-05
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Study First Posted: 2020-01-09
• Last Update Posted: 2020-01-09
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epileptic elderly patients	Zebinix	Elderly patients with partial-onset seizures

Primary Outcome Measures

Name	Time	Method
Retention rate of ESL treatment as assessed by the number of patients that are still included in the study.	at the end of the study treatment, at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment- adverse events as assessed by adverse events reports	through study completion, an average of 6 months	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.
Quality of life of patients as assessed by NDDIE questionnaire	at each visits required by the study (baseline, 3 months and 6 months)	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.
Incidence of seizures as assessed by the occurrence of seizures	at each visits required by the study (baseline, 3 months and 6 months)	The number and the type of seizures or the number of seizure free in elderly patients will be reported
Observance of the treatment as recorded by the control of the drug administration	through study completion, an average of 6 months	The treatment delivery by the pharmacy be performed to assess the compliance of the treatment.
Quality of life of patients as assessed by QOLIE-10 questionnaire	at each visits required by the study (baseline, 3 months and 6 months)	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.
Quality of life of patients as assessed by QoL-AD questionnaire	at each visits required by the study (baseline, 3 months and 6 months)	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.

Trial Locations

Locations (1)

Centre Hospitalier St Joseph St Luc; 🇫🇷 Lyon, France