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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lacosamide
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br> | Drug: Placebo oral tablet<br>* The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.<br>|
| Experimental: Experimental group<br> | Drug: Lacosamide<br>* The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of weekly seizures (times/week) | The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period | 16-week | 
| Assessment of liver function by serum alanine aminotransferase (U/L) | The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients. | One year | 
| Assessment of renal function by serum creatinine (umol/L) | The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients. | One year | 
| Assessment of white blood cell count ( /L) | The white blood cell count (blood routine) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients. | One year |