Continuous infusion reduces wearing off
- Trial ID
- NCT06965374
- Official Title
- Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes
- Goal
- Continuous infusion reduces wearing off
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 270 participants
- Conditions
- Parkinson Disease
Plain-Language Summary
The goal is to collect real-world quality-of-life data on people with levodopa-responsive advanced Parkinson's who are starting 24-hour subcutaneous foslevodopa/foscarbidopa. Foslevodopa and foscarbidopa are water-soluble prodrugs given as a continuous under-the-skin infusion that convert into levodopa and carbidopa in the body, providing steadier dopamine levels to reduce off time and motor fluctuations compared with intermittent oral dosing. The study is for adults 18 and older whose clinician has already decided to prescribe 24-hour subcutaneous LDp/CDp, excluding anyone with label contraindications, certain skin conditions, or recent participation in an investigational drug trial.
Locations
- IRCCS Oasi SS. Troina /ID# 273507, Troina, Enna, Italy
- Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695, Pozzilli, Isernia, Italy
- ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949, Milan, Milano, Italy
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225, Milan, Milano, Italy
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434, Naples, Napoli, Italy
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276, Turin, Piedmont, Italy
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834, Rome, Roma, Italy
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562, Rome, Roma, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539, Rome, Roma, Italy
- Azienda Ulss 3 Serenissima /ID# 273027, Venice, Venezia, Italy
- Azienda Ospedaliero Universitaria delle Marche /ID# 272694, Ancona, Italy
- Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463, Bologna, Italy
- IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628, Messina, Italy
- Azienda Ospedale-Universita Padova /ID# 274317, Padova, Italy
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863, Palermo, Italy
- Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226, Pavia, Italy
- Azienda Ospedaliero Universitaria Pisana /ID# 273541, Pisa, Italy
- AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388, Reggio Emilia, Italy
- AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319, Salerno, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to collect real-world quality-of-life data on people with levodopa-responsive advanced Parkinson's who are starting 24-hour subcutaneous foslevodopa/foscarbidopa. Foslevodopa and foscarbidopa are water-soluble prodrugs given as a continuous under-the-skin infusion that convert into levodopa and carbidopa in the body, providing steadier dopamine levels to reduce off time and motor fluctuations compared with intermittent oral dosing. The study is for adults 18 and older whose clinician has already decided to prescribe 24-hour subcutaneous LDp/CDp, excluding anyone with label contraindications, certain skin conditions, or recent participation in an investigational drug trial.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 19 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 2 years.