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
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.
Study Type
OBSERVATIONAL
Enrollment
200
lacosamide as first add on therapy
Beijing Children's Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Jinan University
The change in seizure frequency per 4 week from retrospective baseline to the maintenance period
The seizure frequency is standardized to a 4 week duration
Time frame: up to 26 weeks
≥50responder rate
percentage of subjects with a 50 % or greater reduction in seizure frequency per 4 weeks from retrospective baseline to maintenance
Time frame: up to 26 weeks
Seizure freedom rate
percentage of subjects who achieved seizure-free during maintenance period
Time frame: up to 26 weeks
Retention rate
the percentage of patients continuing lacosamide at the end of a specified period
Time frame: up to 26 weeks
Cognitive function
Cognitive function in elderly children aged greater than or equal to 6 years is assessed by Wechsler Intelligence Scale for Children-Revised (WISC-RC) ;
Time frame: up to 26 weeks
Cognitive function
Cognitive function in young children aged less than 6 years is assessed by Chinese Wechsler Young Children scale of Intelligence(C - WYCSI)
Time frame: up to 26 weeks
Evaluation for anxiety status
using by seven-item Generalized Anxiety Disorder scale (GAD-7)
Time frame: up to 24 weeks
Evaluation for depression status
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Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangshu, China
The Children's Hospital Affiliated to Suzhou University
Suzhou, Jiangshu, China
Wuhan Children's Hospital
Wuhan, JiangShu, China
...and 9 more locations
using by Neurological Disorders Depression Inventory for Epilepsy(NDDI-E)
Time frame: up to 24 weeks