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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AbbVie
Study ID
NCT07227896
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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 earlier within advanced Parkinson disease under routine clinical practice. Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 100 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 40 sites across the world. Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 6 months. There are no additional examinations due to the study but the participants and caregivers will need to fill several questionnaires to generate data on their motor function and well-being

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Foslevodopa/Foscarbidopa
    Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Primary Outcome Measure

Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV [ Time Frame: Up to approximately 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical Center Health SystemBostonMassachusetts02118-

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