KCT0000512招募中未知
Safety and efficacy of eslicarbazepine acetate (ESL) as adjunctive for partial seizures in elderly patients
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- Pharmanet
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 65(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •At Visit 1 (Screening), patient must be/have
- •1. writtem informed consent;
- •2. of age 65 years or older;
- •3. a documented diagnosis of epilepsy for at least 12 months;
- •4. at least 1 partial-onset seizure (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised)in the 4 weeks prior to Screening;
- •5. 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);
- •6. willing and able to comply with all trial requirements, in the judgement of the investigator.
- •At Visit 2 (start of ESL treatment), patient must have;
- •7. at least 2 partial-onset seizures (documented in the diary) during the 8-week baseline period.
- •8. satisfactorily complied with the study requirements during the baseline period.
排除标准
- •1. only simple partial seizures with no motor symptomatology (classifided as A2-4 according to the International Classification of Epileptic Seizures);
- •2. primarily generalised seizures;
- •3. known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
- •4. occurrence of seizures too close to count accurately;
- •5. history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening;
- •6. seizures of non-epileptic origin;
- •7. major psychiatric disorders;
- •8. history of suicide attempt;
- •9. currently treated with oxcarbazepine;
- •10. previous use of ESL or participation in a clinical study with ESL;
- •11. known hypersensitivity to other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine)or to any of the excipients;
- •12. uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo-or hyper thyroidism of any type;
- •13. second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECGT) as determined by the investigator;
- •14. relevant clinical laboratory abnormalities as determined by the investigator(e.g.,plasmasodium<130 mmol/L, alanine or aspartate aminotransferases>2.0 times above the upper limit of the normal range, or white blood cell count<3,000 cells/mm
- •15. calculated creatinine clearance values < 30mL/min at screening;
- •16. any other condition or circumstance that, in the opinion of the investigator, may compromise the patients's ability to comply with the study protocol;
- •17. 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.
- •18. positive for HLS-B*1502 (patients form Asian countries only)
研究者
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