Opicapone 50 mg for Parkinson's (NCT07403799)
Reduce wearing off motor fluctuations
- Trial ID
- NCT07403799
- Official Title
- Real-life, Observational Study on Opicapone in Patients With Parkinson's Disease and Early Motor Fluctuations in Italy
- Goal
- Reduce wearing off motor fluctuations
- Status
- ACTIVE_NOT_RECRUITING
- Sponsor
- Bial - Portela C S.A.
- Study Type
- OBSERVATIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson Disease
- Interventions
- Opicapone 50 mg
Summary For Families
The goal is to see how opicapone works in real-life care to reduce early end-of-dose wearing off and cut down OFF time for people with Parkinson's. Opicapone 50 mg is a once daily peripheral COMT inhibitor, it slows the enzyme that breaks down levodopa outside the brain so levodopa stays available longer and on-time is extended; patients join after their doctor has already decided to start the drug. They are looking for adults 30 and older with PD (Hoehn and Yahr stages I to III) who have been on levodopa at least one year, have had wearing-off for less than two years, and who are not already on a COMT inhibitor or judged to have dementia or other forms of parkinsonism.
Locations
- 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
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Opicapone 50 mg. The goal is to see how opicapone works in real-life care to reduce early end-of-dose wearing off and cut down OFF time for people with Parkinson's. Opicapone 50 mg is a once daily peripheral COMT inhibitor, it slows the enzyme that breaks down levodopa outside the brain so levodopa stays available longer and on-time is extended; patients join after their doctor has already decided to start the drug. They are looking for adults 30 and older with PD (Hoehn and Yahr stages I to III) who have been on levodopa at least one year, have had wearing-off for less than two years, and who are not already on a COMT inhibitor or judged to have dementia or other forms of parkinsonism.
- Who can participate?
- Participants must be at least 30 Years.
- Where is this trial located?
- This trial is recruiting at 20 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Planned visits occur closest to 6 months (±2 months), 12 months (±2 months), 18 months (±2 months), and 24 months (±2 months) after inclusion.