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Completed

NCT Number: NCT02722590

A Study of Fycompa (Perampanel) in Korean Participants

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy, Idiopathic Generalized Nervous System Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungju, Chungcheong-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
  • 7 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Events

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

  2. Number of Participants With Adverse Drug Reactions

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

  3. Number of Participants With Unexpected Adverse Events

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

  4. Number of Participants With Serious Adverse Events

    Time frame: 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

    Time frame: Up to 24 weeks

    The CGI-C score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement. Effective outcome is defined as CGI-C score of: very much improved (1), much improved (2), or minimally improved (3).

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

Post-Marketing Surveillance of Fycompa in Korean Patients

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2016
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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