Status:

UNKNOWN

A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Lead Sponsor:

Beijing Children's Hospital

Conditions:

Epilepsy

Eligibility:

All Genders

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 e...

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

  • Within 1 year 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;
  • Follow up for at least 3 months;
  • Sign informed consent (if necessary).

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 :

January 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2022

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT05257915

Start Date

January 1 2021

End Date

June 30 2022

Last Update

February 25 2022

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100045

2

Beijing TianTan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

3

Beijing University First Hospital

Beijing, Beijing Municipality, China

4

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure | DecenTrialz