Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease
This study is about a medicine called Foslevodopa/Foscarbidopa, which is already approved for treating Parkinson's disease. Parkinson's is a brain condition that gets worse over time, causing tremors, stiffness, and slow movement. We want to understand how this medicine helps adult patients with advanced Parkinson's disease when it's used in their regular care. About 100 people around the world who are prescribed this medicine will take part. We'll follow them for up to six months, asking them and their caregivers to fill out questionnaires about their movement and overall well-being. This will help us learn how the treatment affects their quality of life in real-world settings.
At a glance
What is this study about?
Parkinson's disease is a condition that affects your brain, causing problems with movement like shaking, stiffness, and slow actions. It tends to get worse over time, but how quickly it changes is different for everyone. There's a medicine called Foslevodopa/Foscarbidopa that is already approved for treating Parkinson's disease. It's given as a continuous infusion just under the skin.
This study isn't testing if the medicine works; it's already known to be effective. Instead, we want to learn more about how it helps people in their daily lives, specifically those with advanced Parkinson's disease. We'll be looking at things like how it affects their daily activities, their mood, and their overall well-being – often called 'quality of life'. This information helps doctors and patients understand what to expect from the treatment when used in regular care, not just in controlled trial settings.
Around 100 adult patients from various places will be included in this study. These are people whose doctors have already decided that Foslevodopa/Foscarbidopa is the right treatment for them. They will continue to receive the medicine as prescribed by their doctor, and we'll follow their progress for up to six months. By gathering information from these patients, we can get a clearer picture of the real-world benefits of this treatment.
Key takeaways
- This study focuses on an existing Parkinson's medicine, Foslevodopa/Foscarbidopa.
- It aims to understand the real-world impact on quality of life for patients with advanced Parkinson's.
- You would already be prescribed this medicine by your doctor to join.
- Participation involves filling out questionnaires about your symptoms and well-being.
- The study lasts up to 6 months with no extra medical tests.
- Your decision to join or leave will not affect your usual medical care.
Who may be eligible?
To join this study, your doctor must have already decided that Foslevodopa/Foscarbidopa is the right treatment for you, based on the approved guidelines for the medicine. You need to be an adult between 18 and 80 years old and have Parkinson's disease that responds to levodopa, another common Parkinson's medication. Also, you should have been diagnosed with Parkinson's less than 10 years ago, and experienced changes in your symptoms (like 'on' and 'off' times) for no more than three years. You also need to be willing to fill out questionnaires on a tablet.
However, you can't join if you have certain health conditions mentioned in the medicine's safety information, or if you've already had other advanced treatments for Parkinson's, like deep brain stimulation or other continuous pumps. If you have severe memory problems (a specific score on a memory test) or are already in another research study, you also won't be able to take part. Also, if you have severe skin problems or can't understand the questions well, you might not be suitable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Has your doctor already prescribed Foslevodopa/Foscarbidopa for you?
- Are you between 18 and 80 years old?
- Were you diagnosed with Parkinson's less than 10 years ago?
- Have you experienced changes in your 'on' and 'off' times for no more than 3 years?
- Are you willing to complete questionnaires on a tablet device?
- Have you not had treatments like Deep Brain Stimulation (DBS) or other continuous pump therapies for Parkinson's?
What does participation involve?
If you decide to take part, you'll continue to receive the Foslevodopa/Foscarbidopa medicine exactly as your doctor prescribes it. This means you'll be using the subcutaneous infusion (a continuous drip under the skin) in your everyday life. There won't be any extra tests or examinations because of the study. Instead, the main part of your involvement will be filling out several questionnaires. Your caregivers might also be asked to complete some questionnaires. These questionnaires will ask about your movement, your symptoms, and how you're feeling overall, helping us understand your quality of life. You'll use an electronic device, like a tablet, to fill these out. We will follow your progress for up to six months in total.
Potential risks and benefits
Locations (10)
- Texas Movement Disorder Specialists /ID# 278565Verified postcodeGeorgetown, United States· Recruiting
- Shaare Zedek Medical Center /ID# 276209Verified postcodeJerusalem, Israel· Recruiting
- The Chaim Sheba Medical Center /ID# 276210Verified postcodeRamat Gan, Israel· Recruiting
- Tel Aviv Sourasky Medical Center /ID# 276212Verified postcodeTel Aviv, Israel· Recruiting
- Hadassah Medical Center-Hebrew University /ID# 276211Verified postcodeJerusalem, Israel· Recruiting
- Fundeni Clinical Institute /ID# 277490Verified postcodeBucharest, Romania· Recruiting
- Arcadia Spitale Si Centre Medicale /Id# 277525Verified postcodeIași, Romania· Recruiting
- Neurotim Med /ID# 277500Verified postcodeTimișoara, Romania· Recruiting
- Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499Verified postcodeBrasov, Romania· Not yet recruiting
- University Hospitals Plymouth NHS Trust /ID# 284977Verified postcodePlymouth, United Kingdom· Recruiting
Common questions
What is the main goal of this study?
The main goal is to understand how Foslevodopa/Foscarbidopa, an approved Parkinson's medicine, affects the quality of life and symptoms of people with advanced Parkinson's in their daily routines.
Do I have to take a new medicine if I join?
No, you will only be included if your doctor has already decided to prescribe Foslevodopa/Foscarbidopa as part of your regular treatment. You won't be given any new or experimental medicines.
What will I have to do if I participate?
You'll continue your prescribed treatment and fill out questionnaires on a tablet about your movement and how you feel, for up to six months. Your caregiver might also help with questionnaires.
Are there any extra doctor's appointments or tests?
No, there are no extra medical appointments or tests specifically for this study. You will continue with your usual medical care.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, and your decision will not affect your ongoing medical care or relationship with your doctor.
How to find out more
Lars Bergmann
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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