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