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

Launched by ABBVIE · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called Foslevodopa/Foscarbidopa works for adults with advanced Parkinson's disease, a condition that affects movement and worsens over time. The trial aims to see how this treatment affects not just the patients, but also the quality of life for their caregivers. Around 270 adult participants who are already prescribed this medication will be involved in the study across about 19 sites in Italy.

To be eligible, participants must have a specific type of Parkinson's disease that responds to a treatment called levodopa, and their doctor must have already decided to prescribe Foslevodopa/Foscarbidopa. They will receive this medication through a continuous infusion, meaning it will be delivered slowly into their body through a small tube under the skin. Participants will be followed for up to a year, but there won’t be any extra demands on their time beyond their usual doctor visits. This study is not yet recruiting participants, so it’s important to keep an eye out for updates if you or someone you know might be interested in joining.

Gender

ALL

Eligibility 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