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

Phase 4

• Conditions: Epilepsy
• Interventions: Drug: Placebo oral tablet; Drug: Lacosamide

• Registration Number: NCT04144218
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-11-08
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo oral tablet	-
Experimental group	Lacosamide	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China