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Efficacy, Safety, and Tolerability of Lacosamide Monotherapy for Focal Seizures in Young Children Aged >=1 Month to <=4 Years: A Real-world Study

Efficacy, Safety and Tolerability of Lacosamide or Oxcarbazepine Monotherapy for Twelve-Month in Pediatric Patients(1month ~ 4years) with Focal Seizures: Real-World Clinical Experience

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102846
Enrollment
Unknown
Registered
2025-05-21
Start date
2024-04-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Epilepsy

Interventions

Lacosamide oxcarbazepine treatment group:none

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.1 Years to 4 Years

Inclusion criteria

Inclusion criteria: 1. Children aged >=1 month to <=4 years; 2. Diagnosis of epilepsy, all of which are focal-onset seizures, with or without secondary bilateral tonic-clonic seizures; 3. Have had at least one seizure in the past 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients with a documented allergy or severe intolerance to the active ingredient of LCM/OXC or any excipients present in the drug ; 2.Patients with unreliable or incomplete clinical records; 3.All patients routinely completed the electrocardiogram (ECG) before premedication. Patients who exhibited a second-degree or third-degree atrioventricular block as detected by ECG.

Design outcomes

Primary

MeasureTime frame
seizure frequency;—

Secondary

MeasureTime frame
Adverse events of epilepsy;—

Countries

China

Contacts

Public ContactYue Hu

Children's Hospital of Chongqing Medical University

huyue915@163.com+86 139 8369 2583

Outcome results

None listed

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