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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Perampanel

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).

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, Capital Medical University
  • Hubei
    • Wuhan, Hubei, China, 430015
      • Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • XuZhou, Jiangsu, China, 221002
      • Xuzhou Children's Hospital
  • Shandong
    • Jinan, Shandong, China, 250022
      • Jinan Children's Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300134
      • Tianjin Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: Fycompa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure-free rate of Perampanel	Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period	6 months
Retention rate of Perampanel	Percentage of subjects still using perampanel after the Maintenance Period	6 months
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

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital
• Investigators: Study Chair: Fang Fang, Beijing Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Perampanel
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: BCHsjk-2021-E-108-Y

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No