A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children

Capital Medical University

Status: Unknown

Conditions: Epilepsy

Treatments: Drug: Perampanel

Study type: Observational

Funder types: Other

Identifiers

NCT05274035

BCHsjk-2021-E-108-Y

Details and patient eligibility

About

This study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. The enrolled subjects were epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.

Full description

This is a multi-center, prospective, observational study. Subjects who meet all of the inclusion and none of the exclusion criteria will be received perampanel. Baseline seizure counts (frequency) data is collected by subjects or guardian/legally authorized representative, retrospectively.

It is expected to enroll 1000 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from July 2021 to November 2021. The initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation. The patients were followed up for 6 months and recorded the frequency of seizures and self-assessment of improvement. Safety will be assessed by monitoring and recording of all of AEs and serious adverse events (SAEs), discontinuation during 6 months treatment (patient spontaneous reporting).

Enrollment: 1,000 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥2y, ≤12y;
• Within 3 months before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;
• 1-3 kinds of AEDs have been used, and the optimal dose and course of treatment have been reached, but the effect is not good. Perampanel is used as an additional treatment.

Exclusion criteria

• Patients who have participated in other researches on antiepileptic drugs or medical devices;
• Inaccurate or unreliable clinical records according to the judgment of participating doctors;
• When the database is closed, the expected follow-up time is less than 6 months.

Trial design

1,000 participants in 1 patient group

Perampanel

Description:

Epilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed perampanel additional treatment.

Treatment:

Drug: Perampanel