A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04737837
• Other study ID #: QF-LCM2020-1
• Status: Not yet recruiting
• Start date: January 31, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2021
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Ruipeng Zhang, MA
• Phone: 13654951067
• Email: zhangruipeng[@]qfyy.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Epilepsy
• Focal-Onset Seizure
• Seizures

Intervention

Drug:
• lacosamide
lacosamide as first add on therapy

Locations

Country	Name	City	State
China	Beijing Children's Hospital affiliated to Capital Medical University	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	West China Second Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Children's Hospital Affiliated to Medical College of Zhejiang University	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	Nanjing Brain Hospital	Nanjing	Jiangshu
China	Huashan hospital affiliated to Fudan University	Shanghai	Shanghai
China	The Children's Hospital of Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen Children's Hospital	Shenzhen	Guangdong
China	The Children's Hospital Affiliated to Suzhou University	Suzhou	Jiangshu
China	Wuhan Children's Hospital	Wuhan	JiangShu
China	Wuhan Union Hospital	Wuhan	Hubei
China	The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine	Xi'an	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Cost-Effectiveness Analysis(CEA)	CEA=cost/efficacy(C/E)	up to 26 weeks
Primary	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
Primary	=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
Secondary	Seizure freedom rate	percentage of subjects who achieved seizure-free during maintenance period	up to 26 weeks
Secondary	Retention rate	the percentage of patients continuing lacosamide at the end of a specified period	up to 26 weeks
Secondary	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
Secondary	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
Secondary	Evaluation for anxiety status	using by seven-item Generalized Anxiety Disorder scale (GAD-7)	up to 24 weeks
Secondary	Evaluation for depression status	using by Neurological Disorders Depression Inventory for Epilepsy(NDDI-E)	up to 24 weeks