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
Plain-Language Summary
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.