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

Yang Xinwei

Status: Active, not recruiting

Conditions: Focal Epilepsy

Treatments: Drug: perampanel

Study type: Observational

Funder types: Other

Identifiers

NCT05497193

20222126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

(1) Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.

Exclusion criteria

(1) syncope (2) Pseudo-seizure(3)transient ischemic attack