ClinicalTrials.gg
CompletedNCT05225324Updated Jun 22, 2025

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

An observational study in Parkinson Disease, sponsored by Eisai Korea Inc.. Completed at 27 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by Eisai Korea Inc. (part of Eisai Co., Ltd.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
702
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Parkinson Disease by Eisai Co., Ltd. — none open to participants now, none under way, none of them phase 3. Parkinson Disease · Eisai Co., Ltd..

Started
2021
with 1 other
Observational
2 of 18
none open now
Registered
17th of 18
by date

Among the 18 studies in Parkinson Disease by Eisai Co., Ltd., this one is one of 2 that started in 2021, is one of 2 observational ones, and was the 17th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

None of the 18 studies in Parkinson Disease by Eisai Co., Ltd. is open now. The open studies under Parkinson Disease, anywhere →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 18 studies in Parkinson Disease by Eisai Co., Ltd. as a file.
02

Study summary

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.

03

Conditions studied

  • Parkinson Disease

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Keywords

  • Equfina
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ( C)
  6. Participants with a history of to any of the ingredients of Equfina Tablet 50 mg
  7. Pregnant women or women who may be pregnant
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
702 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugEqufina 50 mg

    Equfina 50 mg tablets.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Secondary outcomes

  1. 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.

    Time frame: Baseline up to 24 weeks

07

Study locations

27 sites
  • Site #03
    Cheongju, Chungcheongbuk-do, Korea, Republic of
  • Site #23
    Wonju-si, Gangwon-do, Korea, Republic of
  • Site #11
    Ilsan, Gyeonggi-do, Korea, Republic of
  • Site #22
    Yongin-si, Gyeonggi-do, Korea, Republic of
  • Site #06
    Cheonan, Gyeongsangnam-do, Korea, Republic of
  • Site #09
    Jinju, Gyeongsangnam-do, Korea, Republic of
  • Site #07
    Yangsan-si, Gyeongsangnam-do, Korea, Republic of
  • Site #08
    Iksan, Jeollabuk-do, Korea, Republic of
  • Site #17
    Jeonju-si, Jeollabuk-do, Korea, Republic of
  • Site #18
    Jeonju-si, Jeollabuk-do, Korea, Republic of
  • Site #26
    Jeonju-si, Jeollabuk-do, Korea, Republic of
  • Site #05
    Busan, Korea, Republic of
  • Site #16
    Daegu, Korea, Republic of
  • Site #25
    Daegu, Korea, Republic of
  • Site #20
    Daejeon, Korea, Republic of
  • Site #19
    Gwanju, Korea, Republic of
  • Site #24
    Incheon, Korea, Republic of
  • Site #02
    Jeju, Korea, Republic of
  • Site #21
    Sejong, Korea, Republic of
  • Site #01
    Seoul, Korea, Republic of
  • Site #04
    Seoul, Korea, Republic of
  • Site #10
    Seoul, Korea, Republic of
  • Site #12
    Seoul, Korea, Republic of
  • Site #13
    Seoul, Korea, Republic of
  • Site #14
    Seoul, Korea, Republic of
  • Site #15
    Seoul, Korea, Republic of
  • Site #27
    Ulsan, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Mar 2025, 45 months.

Of 60 industry-sponsored observational studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's 45 months is above that.

Counting every sponsor, half of 439 studies reached it within 47 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2022
First posted
Feb 4, 2022
StartActual
Jun 3, 2021
Primary completionActual
Mar 20, 2025
CompletionActual
Mar 20, 2025
Last update
Jun 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05225324
Lead sponsor
Eisai Korea Inc.
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Jun 3, 2021
Primary completion
Mar 20, 2025
Completion
Mar 20, 2025
Last update
Jun 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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