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Completed

NCT Number: NCT05225324

A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)

The purpose of this study is to describe the following in relation to the safety of Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site #23, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with idiopathic Parkinson's disease experiencing end of dose motor fluctuations who are receiving Equfina Tablet 50 mg as adjunctive treatment to levodopa-containing products
  • Participants who have given their consent to study participation about the use of personal data and medical data

Exclusion criteria

  • Participants taking over monoamine oxidase (MAO) inhibitors (example, selegiline hydrochloric acid [HCl], rasagiline mesylate)
  • Participants taking opioid drugs (example, pethidine HCl containing drugs, tramadol HCl containing products or tapentadol HCl)
  • Participants taking serotonergic drugs (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitor, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, noradrenergic and serotonergic antidepressant) or psychostimulant drugs (example, methylphenidate HCl, lisdexamfetamine dimesylate)
  • Participants taking dextromethorphan
  • Participants with severe hepatic impairment (Child-Pugh C)
  • Participants with a history of hypersensitivity to any of the ingredients of Equfina Tablet 50 mg
  • Pregnant women or women who may be pregnant

Treatment and study plan

Equfina 50 mg

Drug

Equfina 50 mg tablets.

Primary outcomes

  1. Number of Participants With SAEs

    Time frame: From first dose of study drug up to 24 weeks

    A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.

  2. Number of Participants With ADRs

    Time frame: From first dose of study drug up to 24 weeks

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.

  3. Number of Participants With Unexpected AEs

    Time frame: From first dose of study drug up to 24 weeks

    An AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, which do not necessarily have a causal relationship with the drug in question. An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug.

  4. Number of Participants With Unexpected ADRs

    Time frame: From first dose of study drug up to 24 weeks

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug.

  5. Number of Participants With Known ADRs

    Time frame: From first dose of study drug up to 24 weeks

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. Known ADRs are those listed in product licensure/notification of the drug.

  6. Number of Participants With Non-serious ADRs

    Time frame: From first dose of study drug up to 24 weeks

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.

Secondary outcomes

  1. Change From Baseline in Score of Clinical Global Impression of Change (CGIC)

    Time frame: Baseline up to 24 weeks

    The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

Equfina Tablet 50 mg Post Marketing Surveillance Protocol

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2022
Registry last updated
Jun 22, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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