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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
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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kliniken Schmieder - Allensbach /ID# 285402
Coordinator of this site? Confirm its status
AllensbachGermanyRecruiting
Knappschaftskrankenhaus Bottrop /ID# 274284
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BottropGermanyRecruiting
Klinikum Bremen-Nord /ID# 275822
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BremenGermanyRecruiting
Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
Klinikum Lippe Detmold /ID# 279451
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DetmoldGermanyRecruiting
Klinikum Dortmund Klinikzentrum Mitte /ID# 280222
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DortmundGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167
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DresdenGermanyRecruiting
Universitaetsklinikum Erlangen /ID# 280831
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ErlangenGermanyRecruiting
Praxis MD Oehlwein /ID# 274222
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GeraGermanyRecruiting
Krankenhaus Martha-Maria Halle-Dolau /ID# 274174
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HalleGermanyRecruiting
Universitaetsklinikum Heidelberg /ID# 274164
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HeidelbergGermanyRecruiting
Klinikum Ingolstadt /ID# 280573
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IngolstadtGermanyRecruiting
Universitaetskliniken Giessen und Marburg /ID# 274224
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MarburgGermanyRecruiting
Klinikum der Universitaet Muenchen Grosshadern /ID# 274168
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MunichGermanyRecruiting
Klinikum Ernst von Bergmann /ID# 274176
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PotsdamGermanyRecruiting
Asklepios Fachklinikum Stadtroda /ID# 274162
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StadtrodaGermanyRecruiting
Universitaetsklinikum Tuebingen /ID# 275828
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TübingenGermanyRecruiting
Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
Coordinator of this site? Confirm its status
UlmGermanyRecruiting
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
Coordinator of this site? Confirm its status
WolfachGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.