ZEBinix® Retention Rate in Epilepsy in Elderly Patients

NCT04221282 | Unknown DMC FDA Drug

• 1 other identifier: ZEBRE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Aging Disorder; Aging; Epilepsy; Seizure

Keywords

epilepsy; elderly; aging; zebinix; Eslicarbazepine acetate; tolerance; antiepileptic drug

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of life of patients as assessed by QOLIE-10 questionnaire

  at each visits required by the study (baseline, 3 months and 6 months)

• Quality of life of patients as assessed by QoL-AD questionnaire

  at each visits required by the study (baseline, 3 months and 6 months)

• Quality of life of patients as assessed by NDDIE questionnaire

  at each visits required by the study (baseline, 3 months and 6 months)

• Incidence of treatment- adverse events as assessed by adverse events reports

  through study completion, an average of 6 months

• Incidence of seizures as assessed by the occurrence of seizures

  at each visits required by the study (baseline, 3 months and 6 months)

Study Arms (1)

Epileptic elderly patients

Elderly patients with partial-onset seizures

Drug: Zebinix

Interventions

Zebinix DRUG

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.

Also known as: Eslicarbazepine acetate (ESL)

Epileptic elderly patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 65 years
• Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion)
• Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures
• At least one seizure in the last three months
• Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy

You may not qualify if:

• History of ESL treatment
• History of status epilepticus, seizures occurring in cluster, pseudo-seizures
• History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 times ULN, gamma-glutamyltranspeptidase (GGT) \> 5 times ULN)
• History of severe renal impairment (clearance CLCR \<30ml/min)
• History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine)
• History of severe hyponatremia (\< 120 mmol/L)
• Second or third degree atrioventricular block
• More than one other antiepileptic drug

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Study Sites (1)

Centre Hospitalier St Joseph St Luc

Lyon, 69007, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adrien DIDELOT, MD, PhD

  Centre Hospitalier saint Joseph St Luc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien DIDELOT, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: January 9, 2020
• Study Start: April 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

FR (1)