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
Plain-Language Summary
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.