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.

Sponsors

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator: Tongji Hospital
Michigan State University
Juntendo University
Technische Universität München
RIKEN
University of California, Los Angeles

Source 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.

Overall Status Recruiting
Start Date 2019-11-08
Completion Date 2021-12-01
Primary Completion Date 2021-10-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Frequency of weekly seizures (times/week) 16-week
Assessment of liver function by serum alanine aminotransferase (U/L) One year
Assessment of renal function by serum creatinine (umol/L) One year
Assessment of white blood cell count ( /L) One year
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lacosamide

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

Arm Group Label: Experimental group

Intervention Type: Drug

Intervention Name: Placebo oral tablet

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

Arm Group Label: Control group

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.

Gender:

All

Minimum Age:

4 Years

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Jing Wang

Phone: +86 057187767138

Email: [email protected]

Location
Facility: Status: Contact: Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University Jing Wang +86 057187767138 [email protected]
Location Countries

China

Verification Date

2019-10-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control group

Type: Placebo Comparator

Label: Experimental group

Type: Experimental

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

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

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