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

Equfina Tablet 50 mg Post Marketing Surveillance Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Equfina 50 mg

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Jina Jieun Kim; Phone Number: +82-10-9708-0744; Email: j16-kim@eisaikorea.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Terminated
    • Site #05
  • Daegu, Korea, Republic of
    • Recruiting
    • Site #16
  • Daegu, Korea, Republic of
    • Active, not recruiting
    • Site #25
  • Daejeon, Korea, Republic of
    • Active, not recruiting
    • Site #20
  • Gwanju, Korea, Republic of
    • Recruiting
    • Site #19
  • Incheon, Korea, Republic of
    • Completed
    • Site #24
  • Jeju, Korea, Republic of
    • Recruiting
    • Site #02
  • Sejong, Korea, Republic of
    • Active, not recruiting
    • Site #21
  • Seoul, Korea, Republic of
    • Recruiting
    • Site #13
  • Seoul, Korea, Republic of
    • Active, not recruiting
    • Site #15
  • Seoul, Korea, Republic of
    • Completed
    • Site #04
  • Seoul, Korea, Republic of
    • Terminated
    • Site #10
  • Seoul, Korea, Republic of
    • Completed
    • Site #01
  • Seoul, Korea, Republic of
    • Active, not recruiting
    • Site #12
  • Seoul, Korea, Republic of
    • Completed
    • Site #14
  • Ulsan, Korea, Republic of
    • Terminated
    • Site #27
  • Chungcheongbuk-do
    • Cheongju, Chungcheongbuk-do, Korea, Republic of
      • Recruiting
      • Site #03
  • Gangwon-do
    • Wonju-si, Gangwon-do, Korea, Republic of
      • Recruiting
      • Site #23
  • Gyeonggi-do
    • Ilsan, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Site #11
    • Yongin-si, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Site #22
  • Gyeongsangnam-do
    • Cheonan, Gyeongsangnam-do, Korea, Republic of
      • Completed
      • Site #06
    • Jinju, Gyeongsangnam-do, Korea, Republic of
      • Completed
      • Site #09
    • Yangsan-si, Gyeongsangnam-do, Korea, Republic of
      • Completed
      • Site #07
  • Jeollabuk-do
    • Iksan, Jeollabuk-do, Korea, Republic of
      • Active, not recruiting
      • Site #08
    • Jeonju-si, Jeollabuk-do, Korea, Republic of
      • Terminated
      • Site #18
    • Jeonju-si, Jeollabuk-do, Korea, Republic of
      • Recruiting
      • Site #26
    • Jeonju-si, Jeollabuk-do, Korea, Republic of
      • Completed
      • Site #17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants administered with Equfina Tablet 50 mg tablet will be enrolled in this study.

Description

Inclusion Criteria:

1. 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
2. Participants who have given their consent to study participation about the use of personal data and medical data

Exclusion Criteria:

1. Participants taking over monoamine oxidase (MAO) inhibitors (example, selegiline hydrochloric acid [HCl], rasagiline mesylate)
2. Participants taking opioid drugs (example, pethidine HCl containing drugs, tramadol HCl containing products or tapentadol HCl)
3. 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)
4. Participants taking dextromethorphan
5. Participants with severe hepatic impairment (Child-Pugh C)
6. Participants with a history of hypersensitivity to any of the ingredients of Equfina Tablet 50 mg
7. Pregnant women or women who may be pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Equfina 50 mg; Participants who will be prescribed with Equfina 50 mg tablets, orally within the scope of the approved label for Korea under the medical judgment of the investigator will be observed prospectively for 24 weeks.	Drug: Equfina 50 mg; Equfina 50 mg tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With SAEs	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.	From first dose of study drug up to 24 weeks
Number of Participants With ADRs	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.	From first dose of study drug up to 24 weeks
Number of Participants With Unexpected AEs	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.	From first dose of study drug up to 24 weeks
Number of Participants With Unexpected ADRs	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.	From first dose of study drug up to 24 weeks
Number of Participants With Known ADRs	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.	From first dose of study drug up to 24 weeks
Number of Participants With Non-serious ADRs	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.	From first dose of study drug up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Score of Clinical Global Impression of Change (CGIC)	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.	Baseline up to 24 weeks

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Equfina
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ME2125-M082-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No