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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children | Children aged 4~16 years with focal onset seizures |
| |
| Adult | Adults aged >16 years with focal onset seizures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lacosamide | Drug | lacosamide as first add on therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure freedom rate | percentage of subjects who achieved seizure-free during maintenance period | up to 26 weeks |
| Retention rate | the percentage of patients continuing lacosamide at the end of a specified period |
| Measure | Description | Time Frame |
|---|---|---|
| the Cost of epilepsy treatment | To calculate the direct medical costs, including personal expenses and medical insurance reimbursement expenses, mainly include examination expenses, disposal expenses, medicine expenses, hospitalization expenses and other expenses | up to 26 weeks |
| Cost-Effectiveness Analysis(CEA) |
Inclusion Criteria:
Exclusion Criteria:
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Adult and children patients (aged 4~75 years) with uncontrolled focal onset seizures and receiving only one baseline AED
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruipeng Zhang, MA | Contact | 13654951067 | zhangruipeng@qfyy.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dong Zhou, Doctor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | China |
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| 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) ; | 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) | up to 26 weeks |
| Evaluation for anxiety status | using by seven-item Generalized Anxiety Disorder scale (GAD-7) | up to 24 weeks |
| Evaluation for depression status | using by Neurological Disorders Depression Inventory for Epilepsy(NDDI-E) | up to 24 weeks |
CEA=cost/efficacy(C/E) |
| up to 26 weeks |
| The First Affiliated Hospital of Jinan University | 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 |
|
| The First Hospital of Jilin University | Changchun | Jilin | China |
| The First Affiliated Hospital of China Medical University | Shenyang | Liaoning | China |
|
| Shandong Provincial Hospital | Jinan | Shandong | China |
|
| Huashan hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
| The Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine | Xi’an | Shanxi | China |
|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
|
| West China Second Hospital of Sichuan University | Chengdu | Sichuan | China |
| Children's Hospital Affiliated to Medical College of Zhejiang University | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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