NCT04608799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

October 20, 2020

Last Update Submit

October 28, 2020

Conditions

Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

PerampanelDRUG

Efficacy of epilepsy drugs

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients suffering from epilepsy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

perampanel

Study Officials

  • WangTso Lee, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 29, 2020

Study Start

January 1, 2018

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)