Clinical trial NCT05274035: A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
Official title: A Multi-center, Real-world Clinical Study of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Epilepsy
Perampanel
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: 50% response rate of Perampanel
timeFrame: 6 months
Secondary outcomes:
measure: Seizure-free rate of Perampanel
timeFrame: 6 months
measure: Retention rate of Perampanel
timeFrame: 6 months
measure: Incidence of AEs and discontinuation [Safety and Tolerability]
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
city: Wuhan
country: China
facility: Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: XuZhou
country: China
facility: XuZhou Children's Hospital
state: Jiangsu
city: Jinan
country: China
facility: Jinan Children's Hospital
state: Shandong
city: Tianjin
country: China
facility: Tianjin Children's Hospital
state: Tianjin
Study officials:
affiliation: Beijing Children's Hospital
name: Fang Fang
role: STUDY_CHAIR
References: