NCT02722590

Brief Summary

The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse event/adverse drug reaction profile, unexpected adverse event/adverse drug reaction profile, already known adverse drug reaction profile, non-serious adverse event profile and other information related to the product's safety and effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,692

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 9, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

March 24, 2016

Last Update Submit

August 2, 2021

Conditions

Epilepsy

Keywords

EpilepsyPartial-onset seizuresSecondarily generalized seizuresPerampanelPost marketing surveillancePrimary generalized tonic-clonic seizuresIdiopathic generalized epilepsy

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Adverse Events

    From the first Fycompa (Perampanel) administration date up to 24 weeks

  • Number of Participants With Adverse Drug Reactions

    From the first Fycompa (Perampanel) administration date up to 24 weeks

  • Number of Participants With Unexpected Adverse Events

    From the first Fycompa (Perampanel) administration date up to 24 weeks

  • Number of Participants With Serious Adverse Events

    From the first Fycompa (Perampanel) administration date up to 24 weeks

Secondary Outcomes (1)

  • Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores

    Up to 24 weeks

Study Arms (1)

All Participants

Participants who are prescribed Fycompa (Perampanel) film-coated tablets and oral suspension per approved prescribing information in a normal clinical practice setting will be enrolled and observed prospectively for up to 24 Weeks.

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female Korean participants who are prescribed with Fycompa (Perampanel) per the approved prescribing information will be enrolled in the study.

You may qualify if:

  • Participants with approved indication for Fycompa (Perampanel) in Korea as follows:
  • Monotherapy (film-coated tablets)
  • o 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
  • Adjunctive therapy (film-coated tablets \& oral suspension)
  • years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
  • years and older Primary generalized tonic-clonic seizures: therapy for treatment of primary generalized tonic-clonic seizures in participants with idiopathic generalized epilepsy
  • Participants who have written consent for use of personal and medical information for the study purpose

You may not qualify if:

  • Hypersensitivity to the active substance or to any of the excipients of this medicine
  • In case of Fycompa film-coated tablets, Fycompa tablets contains lactose; therefore, participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. In case of Fycompa oral suspension, Fycompa suspension contains sorbitol; therefore, participants with rare hereditary problems of fructose intolerance should not take this medicine.
  • Other participants judged to be inadequate to participate in the study by doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Chungju, Chungcheong-do, South Korea

Location

Unknown Facility

Wŏnju, Gangwon-do, South Korea

Location

Unknown Facility

Seongnam, Gyeonggji-do, South Korea

Location

Unknown Facility

Jinju, Gyeongsang-do, South Korea

Location

Unknown Facility

Gwangju, Jeolla-do, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

EpilepsyEpilepsy, Idiopathic Generalized

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

March 30, 2016

Study Start

July 1, 2016

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 9, 2021

Record last verified: 2021-06

Locations

KR(9)