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NCT07403799Active, not recruiting

REal-life ON PARKinson's - ITaly (REONPARK-IT)

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

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

The present study aims to evaluate the effectiveness and safety of opicapone in a real-world setting at centers for Parkinson's disease located in Italy.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
200 (actual)
First submitted
4 Feb 2026
Start date
Jul 2025
Primary completion date
Oct 2028
Lead sponsor
Bial - Portela C S.A.
NCT number
NCT07403799

What you commit to

  • Study type: Observational
  • Participants enrolled: 200
  • From Jul 2025 to the primary completion date, Oct 2028
  • 20 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

  • The patient is participating in a clinical trial with an investigational drug or has concluded participation within 30 days.
  • The patient is currently treated with catechol-O-methyl transferase (COMT) inhibitors.

Other illness

  • The patient meets criteria for dementia in the Investigator's judgment.

Other

  • The patient has any form of Parkinsonism other than PD.
  • The patient has any contraindication to opicapone according to SmPC.

Who the study is looking for

  • The patient is able to comprehend and willing to provide written informed consent to participate in this study.
  • Patients aged 30 years or older.
  • 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).
  • Disease severity stages I-III (Hoehn \& Yahr Staging).
  • The patient is on treatment with levodopa/DOPA decarboxylase inhibitors (DDCI) for at least 1 year.
  • The patient has signs of wearing off phenomenon/end-of dose motor fluctuations for less than 2 years.
  • 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.

Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI
Coordinator of this site? Confirm its status
BariItalyUnknown status
ASST Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
ARNAS Azienda Ospedaliera Brotzu
Coordinator of this site? Confirm its status
CagliariItalyUnknown status
Ospedale Mater Domini
Coordinator of this site? Confirm its status
CatanzaroItalyUnknown status
Ospedale Ss Annunziata
Coordinator of this site? Confirm its status
ChietiItalyUnknown status
Ospedale Policlinico San Martino
Coordinator of this site? Confirm its status
GenovaItalyUnknown status
Centro Neurolesi Bonino Pulejo Messina/IRCCS
Coordinator of this site? Confirm its status
MessinaItalyUnknown status
Istituto Neurologico Carlo Besta - Fondazione IRCCS
Coordinator of this site? Confirm its status
MilanItalyUnknown status
ASST Gaetano Pini CTO, Centro Parkinson
Coordinator of this site? Confirm its status
MilanItalyUnknown status
U.O di Neurologia, Policlinico P. Giaccone
Coordinator of this site? Confirm its status
PalermoItalyUnknown status
Fondazione Mondino
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PaviaItalyUnknown status
Azienda Ospedaliera di Perugia - Santa Maria della Misericordia
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PerugiaItalyUnknown status
Ospedale Santa Chiara
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PisaItalyUnknown status
Arcispedale S. Maria Nuova (AUSL RE)
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Reggio EmiliaItalyUnknown status
Policlinico Universitario Fondazione Agostino Gemelli
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Policlinico Universitario Campus Bio-Medico
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RomaItalyUnknown status
Policlinico Umberto I
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RomaItalyUnknown status
Policlinico Tor Vergata
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RomaItalyUnknown status
A.O.U. Città della Salute e della Scienza di Torino
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TurinItalyUnknown status
Ospedale Borgo Roma
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VeronaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.