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Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)

Recruitingn/aAges 18 Years - 67 YearsAllAbbVie
NCT06916507 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 thi

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📋 Eligibility rules (as published)
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, 18-67 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 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
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What it tests

  • Not listed
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Where

19 sites
Kliniken Schmieder - Allensbach /ID# 285402
Allensbach, Germany
Universitaetsklinikum Heidelberg /ID# 274164
Heidelberg, Germany
Universitaetsklinikum Tuebingen /ID# 275828
Tübingen, Germany
Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
Ulm, Germany
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
Wolfach, Germany
Universitaetsklinikum Erlangen /ID# 280831
Erlangen, Germany
Klinikum Ingolstadt /ID# 280573
Ingolstadt, Germany
Klinikum der Universitaet Muenchen Grosshadern /ID# 274168
Munich, Germany

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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