Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Particip… (NCT07227896) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease
United States100 participantsStarted 2026-03-01
Plain-language 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 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable
* A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)
* Adult male or female between 18 and 80 years of age
* Disease duration (time since diagnosis) \<10 years
* Time since motor fluctuations ≤3 years
* H\&Y Stage \<3 in best "on"
* "off" time of 2.5-6 hours per day
* Naïve to LDp/CDp
* Treatment has been optimized with oral/transdermal PD medication in the opinion of the Investigator
* Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in the study
* Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet).
* Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use/Disclosure of Data (AUDD)/Informed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered
Exclusion Criteria:
* History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country
* History of treatment with any Device-Aided Therapy (…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV