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.
- Diseases
- Parkinson disease
- 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
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| ASST Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| ARNAS Azienda Ospedaliera Brotzu Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| Ospedale Mater Domini Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Ospedale Ss Annunziata Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Centro Neurolesi Bonino Pulejo Messina/IRCCS Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Istituto Neurologico Carlo Besta - Fondazione IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Gaetano Pini CTO, Centro Parkinson Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| U.O di Neurologia, Policlinico P. Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Azienda Ospedaliera di Perugia - Santa Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Ospedale Santa Chiara Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Arcispedale S. Maria Nuova (AUSL RE) Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Policlinico Universitario Fondazione Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U. Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Turin | Italy | Unknown status |
| Ospedale Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.