NCT05497193

Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 280 (estimated)
• Sponsor: Yang Xinwei · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.

Detailed description

This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DRUG	perampanel	China's state food and drug administration approved indications for adults and children aged 4 or more focal epileptic hair company or not with secondary comprehensive seizures of epilepsy, adding treatment, in July 2020 to monotherapy without clinical approval, the current domestic perampanel monotherapy clinical effectiveness and safety of focal epilepsy in children have not been reported.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-03-20
• Completion: 2023-10-20
• First posted: 2022-08-11
• Last updated: 2022-08-11

Locations

1 site across 1 country: China