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Clinical Trials in Italy / NCT07403799
Active, not recruiting Observational

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

NCT07403799 · tracked via the Priya Life Science Italy tracker
Sponsor
Bial - Portela C S.A
Phase
Observational
Started
2025-07-08
Last updated
2026-07-13

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Opicapone 50 mg

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.

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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. — 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.

Trial sites (20)

FacilityCityRegionStatus
Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI Bari Italy
ASST Spedali Civili di Brescia Brescia Italy
ARNAS Azienda Ospedaliera Brotzu Cagliari Italy
Ospedale Mater Domini Catanzaro Italy
Ospedale SS Annunziata Chieti Italy
Ospedale Policlinico San Martino Genova Italy
Centro Neurolesi Bonino Pulejo Messina/IRCCS Messina Italy
ASST Gaetano Pini CTO, Centro Parkinson Milan Italy
Istituto Neurologico Carlo Besta - Fondazione IRCCS Milan Italy
U.O di Neurologia, Policlinico P. Giaccone Palermo Italy
Fondazione Mondino Pavia Italy
Azienda Ospedaliera di Perugia (Santa Maria della Misericordia) Perugia Italy
Ospedale Santa Chiara Pisa Italy
Arcispedale S. Maria Nuova (AUSL RE) Reggio Emilia Italy
Policlinico Universitario Campus Bio-Medico Roma Italy
Policlinico Tor Vergata Roma Italy
Policlinico Umberto I Roma Italy
Policlinico Universitario Fondazione Agostino Gemelli Roma Italy
A.O.U Città della Salute e della Scienza di Torino Turin Italy
Ospedale Borgo Roma Verona Italy

Other trials for the same condition

Superior Cervical Ganglion in Parkinson's Disease Recruiting
Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients Starting soon
Design and Validation of Innovative Strategies Based on Dual-Task Approach Active, not recruiting
Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility Active, not recruiting
Sonification Techniques for Gait Training Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07403799 on ClinicalTrials.gov ↗ ← All trials in Italy