RecruitingNCT07403799

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

Sponsor

Bial - Portela C S.A.

Enrollment

200 participants

Start Date

Jul 8, 2025

Study Type

OBSERVATIONAL

Conditions

Parkinson Disease

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

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This Italian observational study is collecting real-world data on how Parkinson's disease patients do when they start a new add-on medication called opicapone, which is used to reduce the "wearing off" effect (when Parkinson's symptoms return before the next levodopa dose). **You may be eligible if...** - You are 30 years or older with a clinical diagnosis of Parkinson's disease - Your disease is in an early to moderate stage (Hoehn & Yahr stages I–III) - You have been on levodopa therapy for at least 1 year - You experience "wearing off" symptoms (your medication stops working before your next dose) and this has been happening for less than 2 years - Your doctor has prescribed opicapone as an addition to your current treatment **You may NOT be eligible if...** - You have severe "wearing off" complications like dyskinesias - You have significant cognitive impairment or dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpicapone 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.

Locations(20)

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

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NCT07403799

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