Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
This study, called EARLY-FOS, is designed to see how effective a medication called foslevodopa/foscarbidopa is for people living with Parkinson's disease. Parkinson's is a brain condition that causes symptoms like tremors, stiffness, and slow movement, and it affects everyone differently. The study will look at adults in Germany who are in the initial stages of advanced Parkinson's and have been prescribed this treatment by their doctors. Foslevodopa/foscarbidopa is already an approved treatment for Parkinson's disease. About 125 adults will take part across 20 different hospitals or clinics in Germany. Participants will receive the medication as an infusion under their skin, as their doctor has prescribed, and will be followed for up to 12 months. There won't be any extra appointments beyond what's usually needed for their care.
At a glance
What is this study about?
This study, called EARLY-FOS, is looking into how well a treatment called foslevodopa/foscarbidopa works for people with Parkinson's disease in their daily lives. Parkinson's is a long-term condition that affects the brain and can cause movement problems like shaking, stiffness, and slowness. While the condition can get worse over time, how quickly this happens is different for everyone.
Foslevodopa/foscarbidopa is a medication that is already approved for treating Parkinson's disease. This study isn't testing a new drug; instead, it's observing how people who are already prescribed this medication by their doctors in Germany are doing. The main goal is to understand its effectiveness in a real-world setting for adults who are in the early stages of advanced Parkinson's.
About 125 adults will be part of this study, recruited from around 20 clinics or hospitals in Germany. These participants will be receiving foslevodopa/foscarbidopa as an infusion under their skin, just as their doctor has prescribed as part of their regular care. The study will follow their progress for up to a year.
Key takeaways
- This study looks at an approved Parkinson's drug in real life.
- It's for adults (18-64) with early advanced Parkinson's in Germany.
- Participants are already prescribed the study medication by their doctor.
- There are no extra appointments or burdens beyond standard care.
- The study lasts up to 12 months.
- It helps us understand treatment effectiveness for future patients.
Who may be eligible?
To join this study, participants need to be adults between 18 and 64 years old who have Parkinson's disease that responds well to levodopa treatment. They must be suitable for foslevodopa/foscarbidopa therapy according to their doctor's assessment and the official guidelines for the medication. Also, they should have been experiencing noticeable movement changes linked to their medication for no more than three years, and their Parkinson's overall should not be too advanced when they are on their medication.
It's important that the decision to treat a patient with foslevodopa/foscarbidopa has already been made by their doctor before they are asked if they want to join this study. This means the study isn't influencing the treatment choice.
You cannot take part if you have previously used certain types of advanced treatments for Parkinson's. Also, if there are any health reasons listed in the official medication leaflet that would prevent you from taking foslevodopa/foscarbidopa, you wouldn't be able to join. Finally, your score on a memory and thinking test (called the Mini Mental State Examination) needs to be 24 or higher.
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.
- Are you an adult between 18 and 64 years old?
- Do you have Parkinson's disease that improves with levodopa treatment?
- Has your doctor already decided you should receive foslevodopa/foscarbidopa?
- Have you been experiencing noticeable 'off' times (when your medication isn't working as well) for three years or less?
- Have you not used other advanced devices or therapies for Parkinson's before?
- Is your memory and thinking generally good (e.g., Mini Mental State Examination score of 24 or higher)?
What does participation involve?
If you join this study, you will continue to receive the foslevodopa/foscarbidopa medication as an infusion under your skin, exactly as your doctor has prescribed for your Parkinson's. Your treatment will be managed by your usual doctor.
The study will last for up to 12 months. During this time, you will attend regular check-up visits at your hospital or clinic. These visits will be part of your routine medical care for Parkinson's, meaning there shouldn't be any extra appointments or burdens on top of what you would normally have.
During these regular visits, your healthcare team will monitor your condition and how you are responding to the treatment, just as they usually would. There are no additional assessments or procedures specifically for the study beyond your standard clinical practice appointments.
Potential risks and benefits
Locations (17)
- Universitaetsklinikum Heidelberg /ID# 274164Verified postcodeHeidelberg, Germany· Recruiting
- Universitaetsklinikum Tuebingen /ID# 275828Verified postcodeTübingen, Germany· Recruiting
- Praxis Prof. Kassubek/Prof. Riecker /ID# 274165Verified postcodeUlm, Germany· Recruiting
- Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161Verified postcodeWolfach, Germany· Recruiting
- Universitaetsklinikum Erlangen /ID# 280831Verified postcodeErlangen, Germany· Recruiting
- Klinikum Ingolstadt /ID# 280573Verified postcodeIngolstadt, Germany· Recruiting
- Klinikum der Universitaet Muenchen Grosshadern /ID# 274168Verified postcodeMunich, Germany· Recruiting
- Klinikum Ernst von Bergmann /ID# 274176Verified postcodePotsdam, Germany· Recruiting
- Universitaetskliniken Giessen und Marburg /ID# 274224Verified postcodeMarburg, Germany· Recruiting
- Knappschaftskrankenhaus Bottrop /ID# 274284Verified postcodeBottrop, Germany· Recruiting
- Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865Verified postcodeCologne, Germany· Recruiting
- Klinikum Lippe Detmold /ID# 279451Verified postcodeDetmold, Germany· Recruiting
Common questions
What is Parkinson's disease?
Parkinson's disease is a brain condition that affects movement, causing symptoms like shaking, stiffness, and slow movements. It can get worse over time, but how quickly varies greatly.
What is foslevodopa/foscarbidopa?
It's an approved medication used to treat Parkinson's disease. In this study, it's given as an infusion under the skin.
Will I receive a new medication if I join?
No, you will receive the same foslevodopa/foscarbidopa medication that your doctor has already prescribed for you as part of your regular care.
Do I have to do extra visits if I join?
No, the study appointments will be your usual, routine check-ups for your Parkinson's care. There are no extra visits specifically for the study.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.
How to find out more
Medical Information Germany
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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