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
Summary For Families
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.
- 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.