A Study to Assess Change in Disease Symptoms in Adult Participants With Advanced Parkinson Disease Using Subcutaneous Foslevodopa/Foscarbidopa in Belgium

Study Identifier
P26-053
CT.gov Identifier
NCT07382440
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+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant diagnosed with Advanced Parkinson's Disease (PD), aged 18 years or older able to provide voluntary informed consent. * Participant evaluated for commercially available continuous subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) in the hospital at the clinician's discretion as part of his/her routine clinical care and the intention to administer subcutaneous LDp/CDp made prior to and independent of recruitment into the study.
    Exclusion Criteria:
    * Participant participating in an interventional research study (not including noninterventional studies) during the administration of LDp/CDp. * Participant evaluated for commercially available continuous subcutaneous LD/CDp outside of the hospital.

    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 Foslevodopa/Foscarbidopa is in treating adult participants with advanced Parkinson Disease under routine clinical practice in Belgium.

    Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 120 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled at 15 sites across Belgium.

    Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 18 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
    Universitair Ziekenhuis Antwerpen /ID# 279434
    Edegem, Antwerpen, Belgium, 2650
    Status
    Recruiting
    Location
    Chu Tivoli /ID# 279455
    La Louvière, Hainaut, Belgium, 7100
    Status
    Recruiting
    Location
    Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 279452
    Tournai, Hainaut, Belgium, 7500
    Status
    Recruiting
    Location
    Jessa Ziekenhuis - Campus Virga Jesse /ID# 279454
    Hasselt, Limburg, Belgium, 3500
    Status
    Recruiting
    Location
    UZ Gent /ID# 279433
    Ghent, Oost-Vlaanderen, Belgium, 9000
    Status
    Recruiting
    Location
    Universitair Ziekenhuis Leuven /ID# 279439
    Leuven, Vlaams-Brabant, Belgium, 3000
    Status
    Recruiting
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