RecruitingNCT06916507

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

Sponsor

AbbVie

Enrollment

125 participants

Start Date

May 6, 2025

Study Type

OBSERVATIONAL

Conditions

Parkinson's Disease

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on patients with early-stage advanced Parkinson's disease in Germany who are starting a continuous under-the-skin infusion therapy called foslevodopa/foscarbidopa (a levodopa-based treatment). The goal is to understand how this therapy works in everyday clinical settings. **You may be eligible if...** - You have been diagnosed with levodopa-responsive idiopathic Parkinson's disease - You are between 18 and 64 years old - Your motor fluctuations (unpredictable "on/off" periods) have been present for 3 years or less - Your Parkinson's severity is below stage 3 on the Hoehn and Yahr scale while on medication - Your doctor has decided to start you on this therapy before approaching you about the study **You may NOT be eligible if...** - You have previously used any device-assisted therapy (such as a pump or deep brain stimulation) - Your cognitive score (MMSE) is below 24, indicating significant memory or thinking problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(17)

Universitaetsklinikum Heidelberg /ID# 274164

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen /ID# 275828

Tübingen, Baden-Wurttemberg, Germany

Praxis Prof. Kassubek/Prof. Riecker /ID# 274165

Ulm, Baden-Wurttemberg, Germany

Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161

Wolfach, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen /ID# 280831

Erlangen, Bavaria, Germany

Klinikum Ingolstadt /ID# 280573

Ingolstadt, Bavaria, Germany

Klinikum der Universitaet Muenchen Grosshadern /ID# 274168

Munich, Bavaria, Germany

Klinikum Ernst von Bergmann /ID# 274176

Potsdam, Brandenburg, Germany

Universitaetskliniken Giessen und Marburg /ID# 274224

Marburg, Hesse, Germany

Knappschaftskrankenhaus Bottrop /ID# 274284

Bottrop, North Rhine-Westphalia, Germany

Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865

Cologne, North Rhine-Westphalia, Germany

Klinikum Lippe Detmold /ID# 279451

Detmold, North Rhine-Westphalia, Germany

Klinikum Dortmund Klinikzentrum Mitte /ID# 280222

Dortmund, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167

Dresden, Saxony, Germany

Krankenhaus Martha-Maria Halle-Dolau /ID# 274174

Halle, Saxony-Anhalt, Germany

Praxis MD Oehlwein /ID# 274222

Gera, Thuringia, Germany

Asklepios Fachklinikum Stadtroda /ID# 274162

Stadtroda, Thuringia, Germany

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