Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting

Study Identifier
P24-820
CT.gov Identifier
NCT06639620
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Parkinson's Disease
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with advanced Parkinson disease with motor complications insufficiently controlled by current therapy * Participants eligible for foscarbidopa / foslevodopa according to French label \& regulation. * Treatment initiation decision prior to and independently from study enrolment
    Exclusion Criteria:
    * Participants with any contraindication to foscarbidopa / foslevodopa. * 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 French adult participants with advanced Parkinson disease under routine clinical practice.

    Foslevodopa/foscarbidopa is an approved drug outside of US for the treatment of Parkinson's Disease. Approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in France.

    Participants will receive foscarbidopa/ foslevodopa 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
    Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843
    Strasbourg, Alsace, France, 67200
    Status
    Not applicable
    Location
    Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182
    Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
    Status
    Not applicable
    Location
    Hospices Civils De Lyon - Direction Des Affaires Médicales /ID# 266404
    Lyon, Auvergne-Rhône-Alpes, France, 69002
    Status
    Not applicable
    Location
    Hôpital La Timone /ID# 265932
    Marseille, Bouches-du-Rhone, France, 13885
    Status
    Not applicable
    Location
    CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927
    Saint-Brieuc, Brittany Region, France, 22027
    Status
    Not applicable
    Location
    Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 266853
    Besançon, Doubs, France, 25000
    Status
    Not applicable
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