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

Epilepsy Clinical Trial

Official title:

A Multi-center, Real-world Clinical Study of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05274035
• Other study ID #: BCHsjk-2021-E-108-Y
• Status: Active, not recruiting
• Start date: July 2, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2022
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 31, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing
China	Jinan Children's Hospital	Jinan	Shandong
China	Tianjin Children's Hospital	Tianjin	Tianjin
China	Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	XuZhou Children's Hospital	XuZhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	50% response rate of Perampanel	Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline	6 months
Secondary	Seizure-free rate of Perampanel	Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period	6 months
Secondary	Retention rate of Perampanel	Percentage of subjects still using perampanel after the Maintenance Period	6 months
Secondary	Incidence of AEs and discontinuation [Safety and Tolerability]	Incidence of all of adverse events (AEs), serious adverse events (SAEs) and discontinuation from treatment	6 months