International Multicenter, Double-blind, Randomized, Placebo-controlled Evaluation of the Efficacy and Safety of Lacosamide in the Treatment of Pediatric Patients With Focal Refractory Epilepsy.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Frequency of weekly seizures (times/week)
研究概览
简要总结
Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification criteria.
- •Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.
- •Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.
排除标准
- •A history of status epilepticus within 3 months prior to screening visits.
- •Poor adherence to previous treatment.
- •Other serious organic diseases, mental illnesses and neurological diseases.
- •Abnormal liver and kidney function and blood routine results.
研究组 & 干预措施
Control group
干预措施: Placebo oral tablet (Drug)
Experimental group
干预措施: Lacosamide (Drug)
结局指标
主要结局
Frequency of weekly seizures (times/week)
时间窗: 16-week
The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period
Assessment of liver function by serum alanine aminotransferase (U/L)
时间窗: One year
The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients.
Assessment of renal function by serum creatinine (umol/L)
时间窗: One year
The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients.
Assessment of white blood cell count ( /L)
时间窗: One year
The white blood cell count (blood routine) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients.
次要结局
未报告次要终点