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

ZEBinix Retention Rate in Epilepsy in Elderly Patients

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.

Study Overview

• Status: Unknown
• Conditions: Epilepsy; Aging; Epilepsy; Seizure; Aging Disorder
• Intervention / Treatment: Drug: Zebinix

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Adrien DIDELOT, MD, PhD; Phone Number: 0033478616172; Email: adidelot@ch-stjoseph-stluc-lyon.fr

Study Locations

• France
  • Lyon, France, 69007
    • Recruiting
    • Centre Hospitalier St Joseph St Luc
    • Contact: Adrien DIDELOT, MD, PhD; Phone Number: 0033478616172

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epileptic elderly patients; Elderly patients with partial-onset seizures	Drug: Zebinix; ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected.; Other Names: Eslicarbazepine acetate (ESL)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Investigators: Principal Investigator: Adrien DIDELOT, MD, PhD, Centre Hospitalier saint Joseph St Luc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: epilepsy; elderly; aging; tolerance; antiepileptic drug; Eslicarbazepine acetate; zebinix
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: ZEBRE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No