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A Real-world Clinical Study to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure
This study is a real-word clinical trial. The purpose of this study is to evaluate the effectiveness and safety of perampanel as an add-on treatment for epileptic seizure. The enrolled subjects were epilepsy patients 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 600 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from January 2021 to October 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).
Age
All ages
Sex
ALL
Healthy Volunteers
No
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing TianTan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing University First Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Start Date
January 1, 2021
Primary Completion Date
October 31, 2021
Completion Date
June 30, 2022
Last Updated
February 25, 2022
600
ACTUAL participants
Perampanel
DRUG
Lead Sponsor
Beijing Children's Hospital
NCT06700356
NCT02531880
NCT05871372
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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