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
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.