NCT04737837

A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy

A Multi-center,Open-label Real-world Study to Evaluate the Efficacy and Pharmaco-economics of Lacosamide as First Add-on Therapy for Adults and Children With Focal Onset Seizures

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 4 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the efficacy, safety, and pharmaco-economics of Lacosamide Tablet as first add-on therapy for uncontrolled focal onset epilepsy ,invetigating effects of lacosamide Tablet on cognitive function of children and anxiety and depression of adults with focal onset seizures In real-world clinical setting

Detailed description

In many real world, lacosamide as the first add-on therapy can significantly improve the seizure freedom rate. Moreover, many pharmacoeconomic studies in Sweden and the United States have confirmed that lacosamide is a more cost-effective option.This is a real-world study to evaluate the efficacy, safety and cost-effectiveness of Generic lacoxamide tablets in the treatment of patients with focal epilepsy. During the trial, patients with focal epilepsy were treated with lacosamide for the first time after the failure of the original antiepileptic drug. At the same time, the cost-effectiveness of Generic lacosamide was evaluated from the perspective of economics, in order to provide the basis for the clinical choice for Chinese epilepsy patients.

Conditions

• Epilepsy
• Focal-Onset Seizure

Interventions

Type	Name	Description
DRUG	lacosamide	lacosamide as first add on therapy

Timeline

• Start date: 2021-01-31
• Primary completion: 2021-11-28
• Completion: 2022-02-28
• First posted: 2021-02-04
• Last updated: 2021-02-04

Locations

19 sites across 1 country: China