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

NCT04144218 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lacosamide

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

DRUG

Placebo oral tablet

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

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • Michigan State University

    collaborator OTHER

  • Juntendo University

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • RIKEN

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144218 on ClinicalTrials.gov