Status:
UNKNOWN
A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
Lead Sponsor:
Beijing Children's Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
2-12 years
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 th...
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) dat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05274035
Start Date
July 2 2021
End Date
July 31 2022
Last Update
March 25 2022
Active Locations (5)
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1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
2
Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430015
3
XuZhou Children's Hospital
Xuzhou, Jiangsu, China, 221002
4
Jinan Children's Hospital
Jinan, Shandong, China, 250022