Symptom changes with subcutaneous Foslevodopa/Foscarbidopa in adults with advanced Parkinson's disease in Belgium
Observational Prospective Study to Evaluate Effectiveness of Subcutaneous Treatment With Foslevodopa/Foscarbidopa in Real Life Setting for Advanced Parkinson's Disease Patients in Belgium.
This project will try subcutaneous Foslevodopa/Foscarbidopa in adults with advanced Parkinson's disease to see how their symptoms change over 18 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 10 sites (Edegem, Antwerpen and 9 other locations) |
| Trial ID | NCT07382440 on ClinicalTrials.gov |
What this trial studies
This is an observational collection of real-world outcomes in roughly 120 adults with advanced Parkinson's disease who are prescribed subcutaneous Foslevodopa/Foscarbidopa by their physicians. Participants receive the infusion as part of routine clinical care at about 15 hospital sites across Belgium and are followed for up to 18 months. Data will be collected during regular clinic visits with no extra procedures beyond standard care. The goal is to document symptom trajectories and treatment use in typical practice settings.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of advanced Parkinson's disease who have been evaluated and prescribed continuous subcutaneous Foslevodopa/Foscarbidopa in a hospital and can give informed consent are eligible.
Not a fit: People not prescribed subcutaneous Foslevodopa/Foscarbidopa, those receiving the therapy outside hospital settings, or those concurrently enrolled in interventional trials are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this could provide real-world information on how subcutaneous Foslevodopa/Foscarbidopa affects symptoms and daily functioning in people with advanced Parkinson's disease.
How similar studies have performed: Foslevodopa/Foscarbidopa has shown benefit in prior clinical trials and is approved, but there are limited real-world observational data on symptom changes with routine subcutaneous infusion.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant diagnosed with Advanced Parkinson's Disease (PD), aged 18 years or older able to provide voluntary informed consent. * Participant evaluated for commercially available continuous subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) in the hospital at the clinician's discretion as part of his/her routine clinical care and the intention to administer subcutaneous LDp/CDp made prior to and independent of recruitment into the study. Exclusion Criteria: * Participant participating in an interventional research study (not including noninterventional studies) during the administration of LDp/CDp. * Participant evaluated for commercially available continuous subcutaneous LD/CDp outside of the hospital.
Where this trial is running
Edegem, Antwerpen and 9 other locations
- Universitair Ziekenhuis Antwerpen /ID# 279434 — Edegem, Antwerpen, Belgium (Recruiting)
- Chu Tivoli /ID# 279455 — La Louvière, Hainaut, Belgium (Recruiting)
- Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 279452 — Tournai, Hainaut, Belgium (Recruiting)
- Jessa Ziekenhuis - Campus Virga Jesse /ID# 279454 — Hasselt, Limburg, Belgium (Recruiting)
- UZ Gent /ID# 279433 — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Universitair Ziekenhuis Leuven /ID# 279439 — Leuven, Vlaams-Brabant, Belgium (Recruiting)
- AZ Sint-Jan Brugge /ID# 279422 — Bruges, West-Vlaanderen, Belgium (Recruiting)
- Az Groeninge Campus Kennedylaan /ID# 279423 — Kortrijk, West-Vlaanderen, Belgium (Recruiting)
- AZ Oostende /ID# 279461 — Ostend, West-Vlaanderen, Belgium (Recruiting)
- AZ-Delta. /ID# 279437 — Roeselare, West-Vlaanderen, Belgium (Recruiting)
Study contacts
- Study coordinator: Clementine Semanaz
- Email: clementine.semanaz@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.