NCT07403799 REal-life ON PARKinson's - ITaly (REONPARK-IT)
| NCT ID | NCT07403799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bial - Portela C S.A. |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-07-08 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Giovanni Fabbrini
PRINCIPAL INVESTIGATOR
Azienda Universitaria Policlinico Umberto I, Roma
Frequently Asked Questions
Who can join the NCT07403799 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07403799 currently recruiting?
Yes, NCT07403799 is actively recruiting participants. Contact the research team at daniela.cigognini@bial.com for enrollment information.
Where is the NCT07403799 trial being conducted?
This trial is being conducted at Bari, Italy, Brescia, Italy, Cagliari, Italy, Catanzaro, Italy and 11 additional locations.
Who is sponsoring the NCT07403799 clinical trial?
NCT07403799 is sponsored by Bial - Portela C S.A.. The principal investigator is Giovanni Fabbrini at Azienda Universitaria Policlinico Umberto I, Roma. The trial plans to enroll 200 participants.
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