Epilepsy
Conditions
Brief summary
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.
Interventions
DRUGLacosamide
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
DRUGPlacebo oral tablet
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Sponsors
Tongji Hospital
Michigan State University
Juntendo University
Technical University of Munich
RIKEN
University of California, Los Angeles
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of weekly seizures (times/week) | 16-week | The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period |
| Assessment of liver function by serum alanine aminotransferase (U/L) | One year | The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients. |
| Assessment of renal function by serum creatinine (umol/L) | One year | The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients. |
| Assessment of white blood cell count ( /L) | One year | 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. |
Countries
China
Contacts
Primary ContactJing Wang
Outcome results
None listed