Clinical trial NCT04737837: A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Focal-Onset Seizure
Keywords: focal onset,lacosamide,CEA,Real-world,first add on
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and children patients (aged 4\~75 years) with uncontrolled focal onset seizures and receiving only one baseline AED

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in seizure frequency per 4 week from retrospective baseline to the maintenance period
timeFrame: up to 26 weeks
measure: ≥50responder rate
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Seizure freedom rate
timeFrame: up to 26 weeks
measure: Retention rate
timeFrame: up to 26 weeks
measure: Cognitive function
timeFrame: up to 26 weeks
measure: Cognitive function
timeFrame: up to 26 weeks
measure: Evaluation for anxiety status
timeFrame: up to 24 weeks
measure: Evaluation for depression status
timeFrame: up to 24 weeks
Other outcomes:
measure: the Cost of epilepsy treatment
timeFrame: up to 26 weeks
measure: Cost-Effectiveness Analysis(CEA）
timeFrame: up to 26 weeks
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital affiliated to Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangshu
city: Suzhou
country: China
facility: The Children's Hospital Affiliated to Suzhou University
state: Jiangshu
city: Wuhan
country: China
facility: Wuhan Children's Hospital
state: JiangShu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan hospital affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: The Children's Hospital of Fudan University
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: West China Second Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Children's Hospital Affiliated to Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: West China Hospital
name: Dong Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: