Parkinson's Trial NCT06965374
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?
- 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 2 years.
- 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?
- Participants will be followed for up to 12 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.