Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 48
- 主要终点
- Number of Subjects With Reported Adverse Events (AE)
研究概览
简要总结
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.
详细描述
Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent form;
- •Of age 65 years or older;
- •A documented diagnosis of epilepsy for at least 12 months,
- •At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
- •Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
- •Willing and able to comply with all trial requirements, in the judgment of the investigator;
- •At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
- •Satisfactorily complied with the study requirements during the baseline period
排除标准
- •Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
- •Primarily generalised seizures;
- •Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
- •Occurrence of seizures too close to count accurately;
- •History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
- •Seizures of non-epileptic origin;
- •Major psychiatric disorders;
- •History of suicide attempt;
- •Currently treated with oxcarbazepine;
- •Previous use of ESL or participation in a clinical study with ESL;
- •Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
- •Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
- •Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
- •Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3;
- •Calculated creatinine values < 30 mL/min at screening;
- •Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
- •Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.
研究组 & 干预措施
Eslicarbazepine Acetate tablets (800 mg)
干预措施: Eslicarbazepine Acetate (Drug)
结局指标
主要结局
Number of Subjects With Reported Adverse Events (AE)
时间窗: throughout the study
An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP. TEAE assessment: * patients who died * patients who died due to Treatment-emergent adverse event (TEAE) * patients with at least one Serious Adverse Event (SAE) * patients with at least one Treatment-emergent Serious Adverse Event (TESAE) * patients prematurely terminated due to TEAE * patients with at least one TEAE * patients with at least one related TEAE * patients with at least one severe TEAE * patients without any TEAE
次要结局
- Change From Baseline in Standardized Seizure Frequency(8-week Baseline Period and 26-week Treatment Period)