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.
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
1,000
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.
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
XuZhou Children's Hospital
Xuzhou, Jiangsu, China
Jinan Children's Hospital
Jinan, Shandong, China
Tianjin Children's Hospital
Tianjin, Tianjin Municipality, China
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
Time frame: 6 months
Seizure-free rate of Perampanel
Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period
Time frame: 6 months
Retention rate of Perampanel
Percentage of subjects still using perampanel after the Maintenance Period
Time frame: 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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.