Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Jing Wang
Data sourced from clinicaltrials.gov
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