Epilepsy
Conditions
Interventions
children(4~16years):lacosamide
adult(>16years):lacosamide
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
4 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to the start of the trial, the informed consent form approved by the ethics committee should be signed voluntarily by the subjects. For minor subjects, the informed consent form should be signed jointly by the subjects themselves (>= 10 years old) and their parents or legal guardians (minors need to be signed by their parents or legal guardians, minors are defined as subjects under 18 years old); 2. Subjects aged from 4 to 75 years old, male or female; 3. Patients with focal seizures (with or without progression to bilateral tonic clonic seizures) according to ILAE 2017 diagnostic criteria; 4. Patients who had taken one antiepileptic drug in the past four weeks and were considered by the researchers to be suitable for the treatment with lakoxamide; 5. Patients with at least 4 episodes per 28 days during the 8-week retrospective baseline period.
Exclusion criteria
Exclusion criteria: 1. Patients who have used lakoxamide in the past; 2. Pregnant and lactating women, and women who refused to use contraception during the trial; 3. Patients with allergy or allergic constitution to any component of lakoxamide or excipients; 4. Patients with a history of status epilepticus in the last 12 months; 5. Subjects with a history of drug / alcohol abuse; 6. Subjects with history of attempted suicide or suicidal ideation in the past 6 months; 7. Those patients who currently use antidepressants, such as anxiolytics or antipsychotics; 8. Patients with progressive diseases affecting the brain and its function; 9. Patients with psychogenic non epileptic seizures; 10. Patients with severe diseases of lung and blood system, malignant tumor, low immune function and psychosis; 11. Patients who need ketogenic diet treatment or have used other drugs that may affect the absorption, distribution, metabolism and excretion of the product in the first 4 weeks of screening period, such as antipsychotics, monoamine oxidase inhibitors, barbiturates (except for combined use as anticonvulsant treatment) and narcotic analgesics; 12. Patients who have had epilepsy brain surgery or plan to have epilepsy surgery in the next four months; 13. Patients considered unsuitable for this trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in seizure frequency per 4 weeks from retrospective baseline to the maintenance period;=50responder rate, defined as percentage of subjects with a 50 % or greater reduction in seizure frequency per 4 weeks from retrospective baseline to maintenance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure freedom rate, defined as percentage of subjects who achieved seizure-free during maintenance period;Retention rate;Evaluation for the anxiety and depression status;Cognitive function assessment; | — |
Countries
China
Contacts
Public ContactZhou Dong
West China Hospital of Sichuan University
Outcome results
None listed