Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy

International Multicenter, Double-blind, Randomized, Placebo-controlled Evaluation of the Efficacy and Safety of Lacosamide in the Treatment of Pediatric Patients With Focal Refractory Epilepsy.

Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.

Inclusion Criteria:

• Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification criteria.
• Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.
• Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.

Exclusion Criteria:

• A history of status epilepticus within 3 months prior to screening visits.
• Poor adherence to previous treatment.
• Other serious organic diseases, mental illnesses and neurological diseases.
• Abnormal liver and kidney function and blood routine results.