The Efficacy of Fycompa (Perampanel) in Children With Epilepsy

Director of Child Neurology, Department of Pediatrics, National Taiwan University Hospital

Fycompa (Perampanel), a new anti-epileptic drug that uses a new mechanism-AMPA receptor antagonist. Its initial indication is for local or generalized epilepsy in children and adults over 12 years old, but its effectiveness in the treatment of epilepsy in children At present, more evidence is still needed. We will study the effectiveness of Fycompa (Perampanel) in the treatment of epilepsy in children under the age of 18. It is expected that the clinical use of Fycompa (Parampanel) in Taiwan will be able to analyze and study the effectiveness of the clinical use of Fycompa (Parampanel) in the treatment of epilepsy in children, and compare it with foreign reports.

Study Overview

• Status: Completed
• Conditions: Neurologic Disorder
• Intervention / Treatment: Drug: Perampanel

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from epilepsy

Description

Inclusion Criteria:

• Patients under 18 years of age suffering from epilepsy
• Patients who are taking Paraampanel

Exclusion Criteria:

• Patients who are not in the above age groups and who are not using parampanel

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of perampanel in young children with drug-resistant epilepsy	Because the current clinical research data on the use of Fycompa (perampanel) in children for the treatment of epilepsy is still insufficient, the purpose of this research is to review the efficacy of this drug in the treatment of children with epilepsy in our hospital in the past, so as to facilitate the future clinical treatment of children with epilepsy. Children have the possibility of therapeutic reference.	17 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: WangTso Lee, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): March 19, 2020
• Study Completion (ACTUAL): March 19, 2020

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (ACTUAL): October 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 201802018RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No