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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The patient is able to comprehend and willing to provide written willing to sign a consent form 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

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