Home › Trials › NCT05225324

Monitoring the safety of Equfina for Parkinson's disease

Equfina Tablet 50 mg Post Marketing Surveillance Protocol

Eisai Inc. · NCT05225324

This study is testing how safe the Equfina Tablet is for people with Parkinson's disease who have motor fluctuations while they are also taking other medications.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorEisai Inc. (industry)
Locations27 sites (Cheongju, Chungcheongbuk-do and 26 other locations)
Trial IDNCT05225324 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety of Equfina Tablet 50 mg in patients with idiopathic Parkinson's disease who experience motor fluctuations. It will collect data on serious adverse events, unexpected adverse reactions, and known non-serious adverse drug reactions associated with the medication. Participants must be receiving Equfina as an adjunctive treatment to levodopa-containing products and provide consent for the use of their medical data. The study will help gather important safety information in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are individuals with idiopathic Parkinson's disease experiencing end of dose motor fluctuations who are currently using Equfina as part of their treatment.

Not a fit: Patients taking certain medications such as MAO inhibitors, opioids, or serotonergic drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety profile of Equfina, potentially improving treatment options for patients with Parkinson's disease.

How similar studies have performed: While this study focuses on post-marketing surveillance, similar studies have successfully provided safety data for other medications in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Cheongju, Chungcheongbuk-do and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Parkinson Disease, Equfina

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.