Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Marketing Surveillance Study of Fycompa Film-coated Tablets in Korean Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02722590
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Brief Summary:
The objective of this post-marketing surveillance study is to observe the safety profile of Fycompa film-coated tablets 2/4/6/8/10/12 milligrams (mg) in a normal clinical practice setting.

Condition or disease
Epilepsy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2426 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Fycompa Film-coated Tablets 2/4/6/8/10/12mg in Korean Patients
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Perampanel

Group/Cohort
Fycompa tablets 2/4/6/8/10/12 mg
Participants who are prescribed Fycompa film-coated tablets 2/4/6/8/10/12 milligrams (mg) per approved prescribing information in a normal clinical practice setting.



Primary Outcome Measures :
  1. Number of Participants with Adverse Events, Serious Adverse Events, and Adverse Drug Reactions [ Time Frame: Per participant, the follow up period is approximately 6 months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female Korean participants aged 12 years and older who were prescribed Fycompa per the approved prescribing information will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Participants with approved indication for Fycompa in Korea: the adjunctive therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older
  • Participants who have written consent for use of personal and medical information for the study purpose

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722590


Contacts
Layout table for location contacts
Contact: Youngji Pyo 82-2-3451-5533 y-pyo@eisaikorea.com

Locations
Layout table for location information
Korea, Republic of
Recruiting
Chungju, Chungcheong-do, Korea, Republic of
Recruiting
Wonju, Gangwon-do, Korea, Republic of
Recruiting
Seongnam, Gyeonggji-do, Korea, Republic of
Recruiting
Jinju, Gyeongsang-do, Korea, Republic of
Recruiting
Gwangju, Jeolla-do, Korea, Republic of
Recruiting
Busan, Korea, Republic of
Recruiting
Daegu, Korea, Republic of
Recruiting
Daejeon, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.

Layout table for additonal information
Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT02722590     History of Changes
Other Study ID Numbers: E2007-M065-505
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: April 2018

Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):
Epilepsy
Partial-onset seizures
secondarily generalized seizures

Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases