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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Placebo oral tablet; Drug: Lacosamide

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jing Wang; Phone Number: +86 057187767138; Email: wangjing5678@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Jing Wang; Phone Number: +86 057187767138; Email: wangjing5678@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: Lacosamide; The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of weekly seizures (times/week)	The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period	16-week
Assessment of liver function by serum alanine aminotransferase (U/L)	The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients.	One year
Assessment of renal function by serum creatinine (umol/L)	The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients.	One year
Assessment of white blood cell count ( /L)	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.	One year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: University of California, Los Angeles; Tongji Hospital; Michigan State University; Technical University of Munich; Juntendo University; RIKEN

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: IR20191016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No