A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure
A Real-world Clinical Study to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure
1 other identifier
observational
600
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedFirst Submitted
Initial submission to the registry
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFebruary 25, 2022
February 1, 2022
10 months
January 25, 2022
February 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (3)
Seizure-free rate of Perampanel
6 months
Retention rate of Perampanel
6 months
Safety and Tolerability
6 months
Study Arms (1)
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.
Interventions
For patients ≥12 years old, the initial dose is 2 mg/d, and according to the clinical response and tolerance of the patient, the dose is increased to the minimum clinically effective dose in increments of 2 mg, and the interval between dose increases is not less than 2 weeks. For patients \<12 years, according to the actual clinical situation, the initial dose and addition plan are judged by the investigator.
Eligibility Criteria
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.
You may qualify if:
- Within 1 year before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;
- 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;
- Follow up for at least 3 months;
- Sign informed consent (if necessary).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fang Fang
Beijing Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
January 25, 2022
First Posted
February 25, 2022
Study Start
January 1, 2021
Primary Completion
October 31, 2021
Study Completion
June 30, 2022
Last Updated
February 25, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share