Reduce off time with infusion
- Trial ID
- NCT07382440
- Official Title
- Observational Prospective Study to Evaluate Effectiveness of Subcutaneous Treatment With Foslevodopa/Foscarbidopa in Real Life Setting for Advanced Parkinson's Disease Patients in Belgium.
- Goal
- Reduce off time with infusion
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson's Disease
Summary For Families
The goal is to see whether giving foslevodopa/foscarbidopa as a continuous subcutaneous infusion can reduce motor fluctuations and "off" time for people with advanced Parkinson's in routine Belgian care. Foslevodopa and foscarbidopa are prodrugs that convert to levodopa and carbidopa after infusion, allowing a steady, under-the-skin delivery of levodopa instead of uneven oral doses, which can smooth plasma levels and often reduce wearing-off; it replaces or supplements oral levodopa under clinician supervision. The study is looking for adults 18 and older with advanced Parkinson's who were evaluated in hospital and already planned to start the commercially available subcutaneous treatment, excluding anyone in another interventional trial or being evaluated for the treatment outside a hospital.
Locations
- Universitair Ziekenhuis Antwerpen /ID# 279434, Edegem, Antwerpen, Belgium
- Chu Tivoli /ID# 279455, La Louvière, Hainaut, Belgium
- Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 279452, Tournai, Hainaut, Belgium
- Jessa Ziekenhuis - Campus Virga Jesse /ID# 279454, Hasselt, Limburg, Belgium
- UZ Gent /ID# 279433, Ghent, Oost-Vlaanderen, Belgium
- Universitair Ziekenhuis Leuven /ID# 279439, Leuven, Vlaams-Brabant, Belgium
- AZ Sint-Jan Brugge /ID# 279422, Bruges, West-Vlaanderen, Belgium
- Az Groeninge Campus Kennedylaan /ID# 279423, Kortrijk, West-Vlaanderen, Belgium
- AZ Oostende /ID# 279461, Ostend, West-Vlaanderen, Belgium
- AZ-Delta. /ID# 279437, Roeselare, West-Vlaanderen, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see whether giving foslevodopa/foscarbidopa as a continuous subcutaneous infusion can reduce motor fluctuations and "off" time for people with advanced Parkinson's in routine Belgian care. Foslevodopa and foscarbidopa are prodrugs that convert to levodopa and carbidopa after infusion, allowing a steady, under-the-skin delivery of levodopa instead of uneven oral doses, which can smooth plasma levels and often reduce wearing-off; it replaces or supplements oral levodopa under clinician supervision. The study is looking for adults 18 and older with advanced Parkinson's who were evaluated in hospital and already planned to start the commercially available subcutaneous treatment, excluding anyone in another interventional trial or being evaluated for the treatment outside a hospital.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 10 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 and 6 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.