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

Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144218
• Other study ID #: IR20191016
• Status: Recruiting
• Phase: Phase 4
• Start date: November 8, 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jing Wang
• Phone: +86 057187767138
• Email: wangjing5678[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Lacosamide
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
• Placebo oral tablet
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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