Real-world foslevodopa/foscarbidopa treatment for adults with early advanced Parkinson's in Germany
German Real-World Evidence Study on the Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson's Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability
This project will test how well subcutaneous foslevodopa/foscarbidopa works for German adults with early-stage advanced Parkinson's disease when given during routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 17 sites (Heidelberg, Baden-Wurttemberg and 16 other locations) |
| Trial ID | NCT06916507 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational follow-up of about 125 adults who are prescribed subcutaneous foslevodopa/foscarbidopa during usual care across roughly 20 sites in Germany. Participants who meet criteria for early-stage advanced, levodopa-responsive Parkinson's disease will be followed for up to 12 months with regular clinic visits and data collection tied to routine care. Treatment is given as prescribed by the participant's clinician, with no experimental intervention or additional burden required beyond standard visits. The study aims to capture real-world effectiveness and tolerability in a defined early-advanced patient group rather than to test efficacy in a controlled trial.
Who should consider this trial
Good fit: Adults 18–64 with levodopa-responsive idiopathic Parkinson's disease, motor fluctuations for ≤3 years, Hoehn and Yahr stage <3 on medication, and considered eligible for foslevodopa/foscarbidopa by their clinician are ideal candidates.
Not a fit: Patients with prior device-aided therapy, dementia (MMSE <24), contraindications per the local drug label, or those outside the age or motor-fluctuation windows are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could provide real-world evidence on how well foslevodopa/foscarbidopa controls motor fluctuations and functions in everyday clinical practice for this patient group.
How similar studies have performed: Randomized trials have demonstrated efficacy of foslevodopa/foscarbidopa products, but prospective real-world data specifically in early-stage advanced patients are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease * Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label * Participant must be an adult male or female, 18-64 years of age * Time since beginning of motor fluctuations ≤ 3 years * The Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition * Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study Exclusion Criteria: * Previous Exposure to any device-aided therapy (DAT). * Any condition included in the contraindications section of the approved local LDp/CDp label. * Participants with Mini mental state examination (MMSE) score \< 24
Where this trial is running
Heidelberg, Baden-Wurttemberg and 16 other locations
- Universitaetsklinikum Heidelberg /ID# 274164 — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Tuebingen /ID# 275828 — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- Praxis Prof. Kassubek/Prof. Riecker /ID# 274165 — Ulm, Baden-Wurttemberg, Germany (Recruiting)
- Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161 — Wolfach, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Erlangen /ID# 280831 — Erlangen, Bavaria, Germany (Recruiting)
- Klinikum Ingolstadt /ID# 280573 — Ingolstadt, Bavaria, Germany (Recruiting)
- Klinikum der Universitaet Muenchen Grosshadern /ID# 274168 — Munich, Bavaria, Germany (Recruiting)
- Klinikum Ernst von Bergmann /ID# 274176 — Potsdam, Brandenburg, Germany (Recruiting)
- Universitaetskliniken Giessen und Marburg /ID# 274224 — Marburg, Hesse, Germany (Recruiting)
- Knappschaftskrankenhaus Bottrop /ID# 274284 — Bottrop, North Rhine-Westphalia, Germany (Recruiting)
- Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865 — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Klinikum Lippe Detmold /ID# 279451 — Detmold, North Rhine-Westphalia, Germany (Recruiting)
- Klinikum Dortmund Klinikzentrum Mitte /ID# 280222 — Dortmund, North Rhine-Westphalia, Germany (Recruiting)
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167 — Dresden, Saxony, Germany (Recruiting)
- Krankenhaus Martha-Maria Halle-Dölau /ID# 274174 — Halle, Saxony-Anhalt, Germany (Recruiting)
- Praxis MD Oehlwein /ID# 274222 — Gera, Thuringia, Germany (Recruiting)
- Asklepios Fachklinikum Stadtroda /ID# 274162 — Stadtroda, Thuringia, Germany (Recruiting)
Study contacts
- Study coordinator: Medical Information Germany
- Email: medinfo.germany@abbvie.com
- Phone: 49 611 1720 1520
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.