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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04144218

Collaborator

Tongji Hospital (Other), Michigan State University (Other), Juntendo University (Other), Technische Universität München (Other), RIKEN (Other), University of California, Los Angeles (Other)

300

Enrollment

Location

Arms

24.8

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Lacosamide Drug: Placebo oral tablet	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

International Multicenter, Double-blind, Randomized, Placebo-controlled Evaluation of the Efficacy and Safety of Lacosamide in the Treatment of Pediatric Patients With Focal Refractory Epilepsy.

Actual Study Start Date :

Nov 8, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group	Drug: Placebo oral tablet The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Experimental: Experimental group	Drug: Lacosamide The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.

Arm

Intervention/Treatment

Placebo Comparator: Control group

Drug: Placebo oral tablet

The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.

Experimental: Experimental group

Drug: Lacosamide

The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
Tongji Hospital
Michigan State University
Juntendo University
Technische Universität München
RIKEN
University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04144218

Other Study ID Numbers:

IR20191016

First Posted:

Oct 30, 2019

Last Update Posted:

May 12, 2020

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Lacosamide

Study Results

No Results Posted as of May 12, 2020