RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Locations (13)

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

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

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167

Dresden, Saxony, Germany

Krankenhaus Martha-Maria Halle-Dölau /ID# 274174

Halle, Saxony-Anhalt, Germany

Praxis MD Oehlwein /ID# 274222

Gera, Thuringia, Germany

Asklepios Fachklinikum Stadtroda /ID# 274162

Stadtroda, Thuringia, Germany