ZEBinix Retention Rate in Epilepsy in Elderly Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Retention rate of ESL treatment as assessed by the number of patients that are still included in the study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Epileptic elderly patients
Elderly patients with partial-onset seizures
干预措施: Zebinix (Drug)
结局指标
主要结局
Retention rate of ESL treatment as assessed by the number of patients that are still included in the study.
时间窗: 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.
次要结局
- Incidence of treatment- adverse events as assessed by adverse events reports(through study completion, an average of 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 seizures as assessed by the occurrence of seizures(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(through study completion, an average of 6 months)
- 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))