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

NCT05274035 | Unknown

• 1 other identifier: BCHsjk-2021-E-108-Y
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Epilepsy

Keywords

Epilepsy; Perampanel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Seizure-free rate of Perampanel

  6 months

• Retention rate of Perampanel

  6 months

• Incidence of AEs and discontinuation [Safety and Tolerability]

  6 months

Study Arms (1)

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.

Drug: Perampanel

Interventions

Perampanel 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.

Also known as: Fycompa

Perampanel

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age ≥2y, ≤12y;
• Within 3 months before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (5)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

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

Wuhan, Hubei, 430015, China

Location

XuZhou Children's Hospital

Xuzhou, Jiangsu, 221002, China

Location

Jinan Children's Hospital

Jinan, Shandong, 250022, China

Location

Tianjin Children's Hospital

Tianjin, Tianjin Municipality, 300134, China

Location

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fang Fang

  Beijing Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 10, 2022
• Study Start: July 2, 2021
• Primary Completion: November 15, 2021
• Study Completion: July 31, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)