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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lacosamide
Placebo oral tablet
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2019
Last Updated
May 9, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Tongji Hospital, Michigan State University, Juntendo University, Technical University of Munich, RIKEN, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04144218
Brief Title
Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Tongji Hospital, Michigan State University, Juntendo University, Technical University of Munich, RIKEN, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Intervention Description
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Primary Outcome Measure Information:
Title
Frequency of weekly seizures (times/week)
Description
The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period
Time Frame
16-week
Title
Assessment of liver function by serum alanine aminotransferase (U/L)
Description
The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients.
Time Frame
One year
Title
Assessment of renal function by serum creatinine (umol/L)
Description
The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients.
Time Frame
One year
Title
Assessment of white blood cell count ( /L)
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Wang
Phone
+86 057187767138
Email
wangjing5678@126.com
Facility Information:
Facility Name
Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wang
Phone
+86 057187767138
Email
wangjing5678@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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