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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGFrequency 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One year
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