Home › Trials › NCT07403799

Real-world opicapone treatment for Parkinson's in Italy

Real-life, Observational Study on Opicapone in Patients With Parkinson's Disease and Early Motor Fluctuations in Italy

Observational Bial - Portela C S.A. · NCT07403799

This project will try opicapone in people with Parkinson's who have early motor fluctuations to see how well it works and how safe it is in routine care in Italy.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages30 Years and up
SexAll
SponsorBial - Portela C S.A. Industry-sponsored
Locations20 sites (Bari and 19 other locations)
Trial IDNCT07403799 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective observational cohort following people with Parkinson's and early motor fluctuations who start opicapone at participating Italian centers. Treatment decisions are made independently by clinicians according to the local product label, and data are collected during routine clinic visits. Patient- and clinician-reported outcomes are captured as available, with planned follow-ups near 6, 12, 18, and 24 months after starting opicapone and a maximum follow-up of two years. The overall program spans about five years including two years of recruitment and two years of follow-up from the last enrolled patient.

Who should consider this trial

Good fit: Ideal candidates are people aged 30 or older with a clinical diagnosis of Parkinson's (Hoehn & Yahr stages I–III), on levodopa/DDCI for at least one year, experiencing motor wearing-off for less than two years, and starting opicapone per local labeling who can give written consent.

Not a fit: Patients with very advanced Parkinson's (Hoehn & Yahr stage IV–V), long-standing motor fluctuations (>2 years), not treated with levodopa, or with contraindications to opicapone are unlikely to benefit from this observational program.

Why it matters

Potential benefit: If successful, the project could show that opicapone reduces wearing-off and improves daily motor control with an acceptable safety profile in everyday clinical practice.

How similar studies have performed: Randomized trials and some real-world reports have previously shown opicapone can reduce OFF time, so this study builds on established evidence in a routine-care setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The patient is able to comprehend and willing to provide written informed consent to participate in this study.
2. Patients aged 30 years or older.
3. The patient has a clinical diagnosis of PD according to the diagnostic criteria of United Kingdom (UK) PD Society Brain Bank (2006) or Movement Disorder Society (MDS) Clinical Criteria (2015).
4. Disease severity stages I-III (Hoehn \& Yahr Staging).
5. The patient is on treatment with levodopa/DOPA decarboxylase inhibitors (DDCI) for at least 1 year.
6. The patient has signs of wearing off phenomenon/end-of dose motor fluctuations for less than 2 years.
7. Patients starting treatment with opicapone as per local Summary of Product Characteristics (SmPC). Initiation of treatment with opicapone will be independent from participation in this observational study and must not be initiated for the purpose of study participation. The decision to treat patients with opicapone will occur before patients are enrolled in the study.

Exclusion Criteria:

1. The patient has any form of Parkinsonism other than PD.
2. The patient is participating in a clinical trial with an investigational drug or has concluded participation within 30 days.
3. The patient has any contraindication to opicapone according to SmPC.
4. The patient meets criteria for dementia in the Investigator's judgment.
5. The patient is currently treated with catechol-O-methyl transferase (COMT) inhibitors.

Where this trial is running

Bari and 19 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 → Find more trials like this →
Conditions Parkinson DiseaseREONPARK-ITOpicapone
Last reviewed 2026-06-13 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.