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

May 4, 2026 updated by: Bial - Portela C S.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective, observational cohort study of patients with Parkinson's Disease and early motor fluctuations treated with opicapone in Italy.

Treatment with opicapone will be independent from participation in this observational study and must not be initiated for the purpose of participating in it. Opicapone will be administered according to the local Summary of Product Characteristics (SmPC).

Data on patients will be collected in accordance with routine clinical visits and examinations starting from the date when patient consent is obtained, and for up to two years after start of treatment with opicapone. The collection of the patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO) will be dictated by the routine clinical practice at each center; thus, scales left blank will not be considered protocol deviations.

Patients will be followed up for a maximum of 2 years (±2 months). Because of the observational design of the study, there are no imposed visits beyond those performed as per clinical practice. Visits are however planned closest to 6 months (±2 months), 12 months (±2 months), 18 months (±2 months), and 24 months (±2 months) after inclusion.

The overall duration of the study will be of approximately 5 years, with 24 months of recruitment and 24 months (±2 months) of follow-up from the last patient in. The End of Study (EOS) is defined as the time when the last enrolled patient has completed 24 months (±2 months) of assessments (unless early termination) after enrolment.

In the event that a patient discontinues opicapone, he/she will be discontinued from the study. Patients discontinued from the study will not be replaced.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI
        • Contact:
          • Giovanni Defazio
      • Brescia, Italy, 25123
        • Recruiting
        • ASST Spedali Civili di Brescia
        • Contact:
          • Andrea Pilotto
      • Cagliari, Italy, 09121
        • Recruiting
        • ARNAS Azienda Ospedaliera Brotzu
        • Contact:
          • Giovanni Cossu
      • Catanzaro, Italy, 88100
        • Recruiting
        • Ospedale Mater Domini
        • Contact:
          • Maurizio Morelli
      • Chieti, Italy, 66100
        • Recruiting
        • Ospedale SS Annunziata
        • Contact:
          • Stefano Sensi
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino
        • Contact:
          • Roberta Marchese
      • Messina, Italy, 98123
        • Recruiting
        • Centro Neurolesi Bonino Pulejo Messina/IRCCS
        • Contact:
          • Angelo Quartarone
      • Milan, Italy, 20126
        • Recruiting
        • ASST Gaetano Pini CTO, Centro Parkinson
        • Contact:
          • Salvatore Bonvegna
      • Milan, Italy, 20133
        • Recruiting
        • Istituto Neurologico Carlo Besta - Fondazione IRCCS
        • Contact:
          • Roberto Cilia
      • Palermo, Italy, 90129
        • Recruiting
        • U.O di Neurologia, Policlinico P. Giaccone
        • Contact:
          • Marco D'Amelio
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Mondino
        • Contact:
          • Micol Avenali
      • Perugia, Italy, 06100
        • Recruiting
        • Azienda Ospedaliera di Perugia (Santa Maria della Misericordia)
        • Contact:
          • Nicola Tambasco
      • Pisa, Italy, 56126
        • Recruiting
        • Ospedale Santa Chiara
        • Contact:
          • Roberto Ceravolo
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale S. Maria Nuova (AUSL RE)
        • Contact:
          • Francesco Cavallieri
      • Roma, Italy, 00168
        • Recruiting
        • Policlinico Universitario Fondazione Agostino Gemelli
        • Contact:
          • Annarita Bentivoglio
      • Roma, Italy, 00133
        • Recruiting
        • Policlinico Tor Vergata
        • Contact:
          • Mariangela Pierantozzi
      • Roma, Italy, 00161
        • Recruiting
        • Policlinico Umberto I
        • Contact:
          • Giovanni Fabbrini
      • Roma, Italy, 00128
        • Recruiting
        • Policlinico Universitario Campus Bio-Medico
        • Contact:
          • Massimo Marano
      • Turin, Italy, 10126
        • Recruiting
        • A.O.U Città della Salute e della Scienza di Torino
        • Contact:
          • Leonardo Lopiano
      • Verona, Italy, 37134
        • Recruiting
        • Ospedale Borgo Roma
        • Contact:
          • Michele Tinazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Opicapone 50 mg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bial - Portela C S.A.

Investigators

  • Principal Investigator: Giovanni Fabbrini, Azienda Universitaria Policlinico Umberto I, Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2025

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT-BIAL-9-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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