Status:
COMPLETED
A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Brief 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 (ADR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2025
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT05225324
Start Date
June 3 2021
End Date
March 20 2025
Last Update
June 22 2025
Active Locations (27)
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1
Site #23
Wŏnju, Gangwon-do, South Korea
2
Site #11
Ilsan, Gyeonggi-do, South Korea
3
Site #22
Yongin-si, Gyeonggi-do, South Korea
4
Site #06
Cheonan, Gyeongsangnam-do, South Korea