The Efficacy of Fycompa (Perampanel) in Children With Epilepsy

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04608799
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Actual Duration (Months): 26.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neurologic Disorder	Drug: Perampanel

Study Design

• Study Type: Observational
• Actual Enrollment: 38 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Director of Child Neurology, Department of Pediatrics, National Taiwan University Hospital
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Mar 19, 2020
• Actual Study Completion Date: Mar 19, 2020

Outcome Measures

Primary Outcome Measures

1. The efficacy of perampanel in young children with drug-resistant epilepsy [17 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04608799
• Other Study ID Numbers: 201802018RIND
• First Posted: Oct 29, 2020
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nervous System Diseases

Study Results

No Results Posted as of Oct 29, 2020