NCT06916507Recruiting
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice. Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany. Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 125 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- 5 May 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- AbbVie
- Diseases
- Parkinson disease
- NCT number
- NCT06916507
What you commit to
- Study type: Observational
- Planned participants: 125
- From 5 May 2025 to the primary completion date, Jun 2028
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous Exposure to any device-aided therapy (DAT).
Other illness
- Any condition included in the contraindications section of the approved local LDp/CDp label.
Other
- Participants with Mini mental state examination (MMSE) score \< 24
Who the study is looking for
- 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, 18-67 years of age
- Time since beginning of motor fluctuations \<= 5 years
- The Hoehn and Yahr (H\&Y) stage \<= 3
- Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study
Age in the registry: 18 years to 67 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kliniken Schmieder - Allensbach /ID# 285402 Coordinator of this site? Confirm its status | Allensbach | Germany | Recruiting |
| Knappschaftskrankenhaus Bottrop /ID# 274284 Coordinator of this site? Confirm its status | Bottrop | Germany | Recruiting |
| Klinikum Bremen-Nord /ID# 275822 Coordinator of this site? Confirm its status | Bremen | Germany | Recruiting |
| Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865 Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Klinikum Lippe Detmold /ID# 279451 Coordinator of this site? Confirm its status | Detmold | Germany | Recruiting |
| Klinikum Dortmund Klinikzentrum Mitte /ID# 280222 Coordinator of this site? Confirm its status | Dortmund | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167 Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Erlangen /ID# 280831 Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Praxis MD Oehlwein /ID# 274222 Coordinator of this site? Confirm its status | Gera | Germany | Recruiting |
| Krankenhaus Martha-Maria Halle-Dolau /ID# 274174 Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| Universitaetsklinikum Heidelberg /ID# 274164 Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Klinikum Ingolstadt /ID# 280573 Coordinator of this site? Confirm its status | Ingolstadt | Germany | Recruiting |
| Universitaetskliniken Giessen und Marburg /ID# 274224 Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Klinikum der Universitaet Muenchen Grosshadern /ID# 274168 Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Ernst von Bergmann /ID# 274176 Coordinator of this site? Confirm its status | Potsdam | Germany | Recruiting |
| Asklepios Fachklinikum Stadtroda /ID# 274162 Coordinator of this site? Confirm its status | Stadtroda | Germany | Recruiting |
| Universitaetsklinikum Tuebingen /ID# 275828 Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
| Praxis Prof. Kassubek/Prof. Riecker /ID# 274165 Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161 Coordinator of this site? Confirm its status | Wolfach | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.