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.
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 12, 2020
October 1, 2019
1.9 years
October 17, 2019
May 9, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Control group
PLACEBO COMPARATORExperimental group
EXPERIMENTALInterventions
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Tongji Hospitalcollaborator
- Michigan State Universitycollaborator
- Juntendo Universitycollaborator
- Technical University of Munichcollaborator
- RIKENcollaborator
- University of California, Los Angelescollaborator
Study Sites (1)
Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 30, 2019
Study Start
November 8, 2019
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
May 12, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share