NCT07403799

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-08
• Primary completion: 2028-10-31
• Completion: 2029-06-30
• First posted: 2026-02-11
• Last updated: 2026-02-12

Locations

20 sites across 1 country: Italy