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
Bial - Portela C S.A.
200 participants
Jul 8, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria5
- 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.
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.
Locations(20)
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NCT07403799