A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
- Conditions
- Epilepsy
- Interventions
- Registration Number
- NCT05274035
- Lead Sponsor
- Beijing Children's Hospital
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Perampanel 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.
- Primary Outcome Measures
Name Time Method 50% response rate of Perampanel 6 months Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline
- Secondary Outcome Measures
Name Time Method Seizure-free rate of Perampanel 6 months Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period
Incidence of AEs and discontinuation [Safety and Tolerability] 6 months Incidence of all of adverse events (AEs), serious adverse events (SAEs) and discontinuation from treatment
Retention rate of Perampanel 6 months Percentage of subjects still using perampanel after the Maintenance Period
Trial Locations
- Locations (5)
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Jinan Children's Hospital
🇨🇳Jinan, Shandong, China
Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tianjin Children's Hospital
🇨🇳Tianjin, Tianjin, China
XuZhou Children's Hospital
🇨🇳XuZhou, Jiangsu, China