Clinical trial NCT04221282: ZEBinix® Retention Rate in Epilepsy in Elderly Patients
Official title: ZEBinix Retention Rate in Epilepsy in Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Aging Disorder
Aging
Epilepsy; Seizure
Keywords: epilepsy
elderly
aging
zebinix
Eslicarbazepine acetate
tolerance
antiepileptic drug
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients ≥ 65 years that undergo at least one seizure in the last three months and with no history of ESL tratment or history of epilepsy status will be screened. ESL will be initiated by the investigator in patients with refractory partial seizures with or without generalized seizures or with PGTC seizures as a first line monotherapy or adjunctive therapy. In case of inefficacy or toxicity the dose of ESL will be gradually titrated up to 1 600 mg or titrated down to 600 mg, respectively.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention rate of ESL treatment as assessed by the number of patients that are still included in the study.
timeFrame: at the end of the study treatment, at 6 months
Secondary outcomes:
measure: Quality of life of patients as assessed by QOLIE-10 questionnaire
timeFrame: at each visits required by the study (baseline, 3 months and 6 months)
measure: Quality of life of patients as assessed by QoL-AD questionnaire
timeFrame: at each visits required by the study (baseline, 3 months and 6 months)
measure: Quality of life of patients as assessed by NDDIE questionnaire
timeFrame: at each visits required by the study (baseline, 3 months and 6 months)
measure: Incidence of treatment- adverse events as assessed by adverse events reports
timeFrame: through study completion, an average of 6 months
measure: Incidence of seizures as assessed by the occurrence of seizures
timeFrame: at each visits required by the study (baseline, 3 months and 6 months)
measure: Observance of the treatment as recorded by the control of the drug administration
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier St Joseph St Luc
Study officials:
affiliation: Centre Hospitalier saint Joseph St Luc
name: Adrien DIDELOT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: