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
1 other identifier
observational
200
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2025
CompletedFirst Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
May 5, 2026
May 1, 2026
3.3 years
February 4, 2026
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment.
To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease and early motor fluctuations by means of the PGI-C at 12 months after start of treatment.
12 months
Study Arms (1)
Cohort 1
To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease (PD) and early motor fluctuations by means of the Patient Global Impression of Change (PGI-C) at 12 months after start of treatment
Interventions
The recommended dose of opicapone is 50 mg. Opicapone must be taken once a day before going to bed, at least one hour before or one hour after levodopa combinations. As opicapone enhances the effects of levodopa, it could be necessary to adjust levodopa dose by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with opicapone.
Eligibility Criteria
The study will be conducted at approximately 20 centers located in Italy and plans to enroll approximately 200 patients with Parkinson's Disease and early motor fluctuations.
You may qualify if:
- 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.
You may not qualify if:
- The patient has any form of Parkinsonism other than PD.
- The patient is participating in a clinical trial with an investigational drug or has concluded participation within 30 days.
- The patient has any contraindication to opicapone according to SmPC.
- The patient meets criteria for dementia in the Investigator's judgment.
- The patient is currently treated with catechol-O-methyl transferase (COMT) inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI
Bari, 70124, Italy
ASST Spedali Civili di Brescia
Brescia, 25123, Italy
ARNAS Azienda Ospedaliera Brotzu
Cagliari, 09121, Italy
Ospedale Mater Domini
Catanzaro, 88100, Italy
Ospedale SS Annunziata
Chieti, 66100, Italy
Ospedale Policlinico San Martino
Genova, 16132, Italy
Centro Neurolesi Bonino Pulejo Messina/IRCCS
Messina, 98123, Italy
ASST Gaetano Pini CTO, Centro Parkinson
Milan, 20126, Italy
Istituto Neurologico Carlo Besta - Fondazione IRCCS
Milan, 20133, Italy
U.O di Neurologia, Policlinico P. Giaccone
Palermo, 90129, Italy
Fondazione Mondino
Pavia, 27100, Italy
Azienda Ospedaliera di Perugia (Santa Maria della Misericordia)
Perugia, 06100, Italy
Ospedale Santa Chiara
Pisa, 56126, Italy
Arcispedale S. Maria Nuova (AUSL RE)
Reggio Emilia, 42123, Italy
Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Policlinico Umberto I
Roma, 00161, Italy
Policlinico Universitario Fondazione Agostino Gemelli
Roma, 00168, Italy
A.O.U Città della Salute e della Scienza di Torino
Turin, 10126, Italy
Ospedale Borgo Roma
Verona, 37134, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Fabbrini
Azienda Universitaria Policlinico Umberto I, Roma
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 11, 2026
Study Start
July 8, 2025
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share