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

NCT ID: NCT05274035

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2022-07-31

Brief Summary

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.

Detailed 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).

Conditions

Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Perampanel

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.

Perampanel

Intervention Type: DRUG

For children ≥4 years old, the initial dose is 2 mg per day, the titration interval is ≥2 weeks, the daily dose is increased by 2 mg each time (based on clinical response and tolerability), and the maintenance dose is ≥4 mg per day, up to a maximum dose of 12 mg per day.

For children <4 years old, the initial dose is 0.04 mg/kg per day, the titration interval is ≥ 2 weeks, the daily dose is increased by 0.04 mg/kg each time (based on clinical response and tolerability), and the maintenance dose is ≥ 0.08 mg/day per day kg, the highest dose is 0.24 mg/kg per day.

According to the actual clinical situation, the initial dose and addition plan are judged by the investigator.

Interventions

Perampanel

For children ≥4 years old, the initial dose is 2 mg per day, the titration interval is ≥2 weeks, the daily dose is increased by 2 mg each time (based on clinical response and tolerability), and the maintenance dose is ≥4 mg per day, up to a maximum dose of 12 mg per day.

For children <4 years old, the initial dose is 0.04 mg/kg per day, the titration interval is ≥ 2 weeks, the daily dose is increased by 0.04 mg/kg each time (based on clinical response and tolerability), and the maintenance dose is ≥ 0.08 mg/day per day kg, the highest dose is 0.24 mg/kg per day.

According to the actual clinical situation, the initial dose and addition plan are judged by the investigator.

Intervention Type: DRUG

Other Intervention Names

Fycompa

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaodan Li, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang Fang

Role: STUDY_CHAIR

Beijing Children's Hospital

Locations

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

XuZhou Children's Hospital

Xuzhou, Jiangsu, China

Jinan Children's Hospital

Jinan, Shandong, China

Tianjin Children's Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

BCHsjk-2021-E-108-Y

Identifier Type: -

Identifier Source: org_study_id