NCT05225324Completed
A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)
Equfina Tablet 50 mg Post Marketing Surveillance Protocol
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 702 (actual)
- First submitted
- 26 Jan 2022
- Start date
- 3 Jun 2021
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- Eisai Korea Inc.
- Diseases
- Parkinson disease
- NCT number
- NCT05225324
What you commit to
- Study type: Observational
- Participants enrolled: 702
- From 3 Jun 2021 to the primary completion date, 20 Mar 2025
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Participants with severe hepatic impairment (Child-Pugh C)
- Participants with a history of hypersensitivity to any of the ingredients of Equfina Tablet 50 mg
Other
- Participants taking dextromethorphan
- Pregnant women or women who may be pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.