Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease

Study Identifier
P25-246
CT.gov Identifier
NCT06965374
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:
    * Participants with a diagnosis of levodopa-responsive advance Parkinson's disease (PD) * Investigator decision on participant treatment with subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) made prior to, and independently, the decision to approach the participant to participate in the study * 24-h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies
    Exclusion Criteria:
    * Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label * Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another Post-Marketing Observational Study (PMOS) or Registry is acceptable * History of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments

    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 Italian adult participants with advanced Parkinson disease under routine clinical practice. This study will also assess the caregiver quality of life (QOL) (if caregiver is present).

    Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 270 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 19 sites in Italy.

    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
    IRCCS Oasi SS. Troina /ID# 273507
    Troina, Enna, Italy, 94018
    Status
    Recruiting
    Location
    Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695
    Pozzilli, Isernia, Italy, 86077
    Status
    Recruiting
    Location
    ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949
    Milan, Milano, Italy, 20122
    Status
    Recruiting
    Location
    Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225
    Milan, Milano, Italy, 20133
    Status
    Recruiting
    Location
    Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434
    Naples, Napoli, Italy, 80138
    Status
    Recruiting
    Location
    A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276
    Turin, Piedmont, Italy, 10126
    Status
    Recruiting
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