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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Juntendo University; Michigan State University; RIKEN; Technische Universität München; Tongji Hospital; University of California, Los Angeles
• Treatments: Lacosamide

Criteria

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.