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

Study Identifier
P25-278
CT.gov Identifier
NCT06916507
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 64 Years
    Inclusion and Exclusion Criteria
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Universitaetsklinikum Heidelberg /ID# 274164
    Heidelberg, Baden-Wurttemberg, Germany, 69120
    Status
    Recruiting
    Location
    Universitaetsklinikum Tuebingen /ID# 275828
    Tübingen, Baden-Wurttemberg, Germany, 72076
    Status
    Recruiting
    Location
    Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
    Ulm, Baden-Wurttemberg, Germany, 89073
    Status
    Recruiting
    Location
    Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
    Wolfach, Baden-Wurttemberg, Germany, 77709
    Status
    Recruiting
    Location
    Universitaetsklinikum Erlangen /ID# 280831
    Erlangen, Bavaria, Germany, 91054
    Status
    Recruiting
    Location
    Klinikum Ingolstadt /ID# 280573
    Ingolstadt, Bavaria, Germany, 85049
    Status
    Recruiting
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