Skip to content

Efficacy and safety of lacosamide in children with epilepsy under 16 years of age

Efficacy and safety of lacosamide in children with epilepsy under 16 years of age

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046564
Enrollment
Unknown
Registered
2021-05-22
Start date
2021-05-25
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy

Interventions

Lacosamide group:Nil
control group:Nil

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 16 Years

Inclusion criteria

Inclusion criteria: 1. Aged =1 in the three months before screening; 4. Informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. The subject has a known allergy to any component of the study drug; 2. Patients whose epileptic seizure frequency cannot be determined in the first three months of enrollment; 3. The subject has taken LCM or participated in a clinical trial of LCM, and was terminated due to lack of efficacy or adverse events; 4. The subject is receiving ketogenic diet therapy; 5. The subject suffers from congenital heart disease, cardiac sodium channel disease, and arrhythmic heart disease that have a significant impact on hemodynamics; 6. The upper limit of normal value (ULN) of the following substances in the subject is> 2 times: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total gallbladder Red pigment>upper limit of normal value (if Gilbert syndrome is known, total bilirubin>1.5 times the upper limit of normal value); 7. Subject's creatinine > 445umol/L; 8. The researcher believes that the subject is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Seizure frequency;

Countries

China

Contacts

Public ContactXiao Nong

Children's Hospital of Chongqing Medical University

xiaonongwl@163.com+86 18983665866

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026