Parkinson DiseaseNCT07403799
REal-life ON PARKinson's - ITaly (REONPARK-IT)
An observational study of Parkinson Disease, run by Bial - Portela C S.A. at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone 50 mg
- How many people
- 200 participants
- Where
- 20 sitesItaly
- Study dates
- 8 Jul 2025to 30 Jun 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at approximately 20 centers located in Italy and plans to enroll approximately 200 patients with Parkinson's Disease and early motor fluctuations.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI
Bari, 70124
ASST Spedali Civili di Brescia
Brescia, 25123
ARNAS Azienda Ospedaliera Brotzu
Cagliari, 09121
Ospedale Mater Domini
Catanzaro, 88100
Ospedale SS Annunziata
Chieti, 66100
Ospedale Policlinico San Martino
Genova, 16132
Centro Neurolesi Bonino Pulejo Messina/IRCCS
Messina, 98123
ASST Gaetano Pini CTO, Centro Parkinson
Milan, 20126
Istituto Neurologico Carlo Besta - Fondazione IRCCS
Milan, 20133
U.O di Neurologia, Policlinico P. Giaccone
Palermo, 90129
Fondazione Mondino
Pavia, 27100
Azienda Ospedaliera di Perugia (Santa Maria della Misericordia)
Perugia, 06100
Ospedale Santa Chiara
Pisa, 56126
Arcispedale S. Maria Nuova (AUSL RE)
Reggio Emilia, 42123
Policlinico Universitario Campus Bio-Medico
Roma, 00128
Policlinico Tor Vergata
Roma, 00133
Policlinico Umberto I
Roma, 00161
Policlinico Universitario Fondazione Agostino Gemelli
Roma, 00168
A.O.U Città della Salute e della Scienza di Torino
Turin, 10126
Ospedale Borgo Roma
Verona, 37134
About this study
Official title: Real-life, Observational Study on Opicapone in Patients With Parkinson's Disease and Early Motor Fluctuations in Italy
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.
Read the 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
- Being tested
- Opicapone 50 mg
- Keywords
- REONPARK-IT, Opicapone
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opicapone 50 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease (PD) and early motor fluctuations by means of the Patient Global Impression of Change (PGI-C) at 12 months after start of treatment Receives: Drug: Opicapone 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment.
To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease and early motor fluctuations by means of the PGI-C at 12 months after start of treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start8 Jul 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Fabbrini, Principal investigator, Azienda Universitaria Policlinico Umberto I, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403799
- Sponsor's protocol ID
- IT-BIAL-9-402
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life, Observational Study on Opicapone in Patients With Parkinson's Disease and Early Motor Fluctuations in Italy
- ClinicalTrials.gov ID
- NCT07403799
- Acronym / sponsor ID
- IT-BIAL-9-402
- Conditions
- Parkinson Disease
- Keywords
- REONPARK-IT, Opicapone
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Opicapone 50 mgTo evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease (PD) and early motor fluctuations by means of the Patient Global Impression of Change (PGI-C) at 12 months after start of treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at approximately 20 centers located in Italy and plans to enroll approximately 200 patients with Parkinson's Disease and early motor fluctuations.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opicapone 50 mgThe 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. | Drug | Cohort 1 |
Primary outcome
Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment.
Time frame: 12 months
To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease and early motor fluctuations by means of the PGI-C at 12 months after start of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Fabbrini principal investigator
Azienda Universitaria Policlinico Umberto I, Roma
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Bial - Portela C S.A. at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.