A Multi-center,Open-label Real-world Study to Evaluate the Efficacy and Pharmaco-economics of Lacosamide as First Add-on Therapy for Adults and Children With Focal Onset Seizures
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- ≥50responder rate
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy, safety, and pharmaco-economics of Lacosamide Tablet as first add-on therapy for uncontrolled focal onset epilepsy ,invetigating effects of lacosamide Tablet on cognitive function of children and anxiety and depression of adults with focal onset seizures In real-world clinical setting
详细描述
In many real world, lacosamide as the first add-on therapy can significantly improve the seizure freedom rate. Moreover, many pharmacoeconomic studies in Sweden and the United States have confirmed that lacosamide is a more cost-effective option.This is a real-world study to evaluate the efficacy, safety and cost-effectiveness of Generic lacoxamide tablets in the treatment of patients with focal epilepsy. During the trial, patients with focal epilepsy were treated with lacosamide for the first time after the failure of the original antiepileptic drug. At the same time, the cost-effectiveness of Generic lacosamide was evaluated from the perspective of economics, in order to provide the basis for the clinical choice for Chinese epilepsy patients.
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
- 4 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before the start of the trial, to obtain the informed consent approved by the ethics committee voluntarily signed by each subject. For underage subjects, the informed consent jointly signed by the subjects themselves (≥10 years ) and their parents or legal guardian (in which the underage needs the signature with their parents or legal guardian, and the underage is defined as the subject under 18 years of age) ;
- •Male and female, between the ages of 4 and 75 years;
- •Diagnostic criteria of focal onset seizures (with or without focal to bilateral tonic clonic seizures) was based on the 2017 Classification of Epileptic Seizures from the International League Against Epilepsy (ILAE);
- •In the 4 weeks before enrollment and during the baseline period, patients have been on only one stable dosage of antiepileptic drug and suitable for lacosamide add-on therapy according to their investigators criteria;
- •During the 8-week retrospective baseline period, patients must have had at least 4 focal onset seizures per 28 days on average.
排除标准
- •Patients had received previous lacosamide treatment;
- •Female patients are pregnant, breast-feeding, and will not use contraception during the trial;
- •Patients had known allergies to lacosamide or any ingredients of the drug, or with allergic constitution;
- •Patients have a history of status epilepticus in the last 12 months;
- •History of chronic alcohol or drug abuse; 6.history of suicide attempt or suicidal ideation in the past 6 months;
- •Current use of Antidepressants, anxiolytics or antipsychotics;
- •Patients suffer from progressive diseases that affect the patient's brain and its function;
- •Sychogenic nonepileptic seizures;
- •Patients suffer from serious lung and blood system diseases, malignant tumor, lower immune function and psychosis;
- •Patients wil receive ketogenic diet therapy, or Four weeks before entering the screening period, patients used other drugs that may affect the absorption, distribution, metabolism and excretion of lacosamide, such as antipsychotics, monoamine oxidase inhibitors, barbiturates (except for combined use as anticonvulsant therapy), narcotic analgesics.
- •Patients Had epilepsy brain surgery, or will undergo epilepsy surgery in the next four months.
- •Investigators considered Patients as unsuitable for this trial.
研究组 & 干预措施
Adult
Adults aged >16 years with focal onset seizures
干预措施: lacosamide (Drug)
children
Children aged 4~16 years with focal onset seizures
干预措施: lacosamide (Drug)
结局指标
主要结局
≥50responder rate
时间窗: up to 26 weeks
percentage of subjects with a 50 % or greater reduction in seizure frequency per 4 weeks from retrospective baseline to maintenance
The change in seizure frequency per 4 week from retrospective baseline to the maintenance period
时间窗: up to 26 weeks
The seizure frequency is standardized to a 4 week duration
次要结局
- Retention rate(up to 26 weeks)
- Evaluation for anxiety status(up to 24 weeks)
- Cognitive function(up to 26 weeks)
- Evaluation for depression status(up to 24 weeks)
- Seizure freedom rate(up to 26 weeks)