Active not recruitingOBSERVATIONAL

Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting

This study is for adults in France who have advanced Parkinson's disease. Researchers want to see how well a medicine called foscarbidopa/foslevodopa works in real-life situations. Parkinson's disease is a brain condition that causes symptoms like shaking, stiffness, and slow movement. This medicine is already approved for use outside the US. About 200 people who are already prescribed this medicine by their doctors will take part. They will receive the medicine as a continuous infusion under the skin, just as their doctor usually prescribes. Participants will be followed for up to 12 months, attending their regular doctor's appointments. This study aims to understand the medicine's effectiveness and any side effects when used in everyday medical practice.

At a glance

Status

Active not recruiting

Sponsor

AbbVie

Enrolment target

250

Start

12 Nov 2024

Estimated completion

01 Mar 2027

Advanced Parkinson Disease

What is this study about?

Parkinson's disease is a condition that affects your brain, causing problems with movement. It can lead to symptoms like shaking (tremors), muscle stiffness, and slow movements. Over time, these symptoms can get worse, but how quickly this happens varies a lot from person to person. For some people, Parkinson's disease can become quite advanced, and their current treatments might not be managing their symptoms as well as they used to.

This study focuses on a specific medicine called foscarbidopa/foslevodopa. This medicine is already approved for use in Parkinson's disease outside of America. The main goal of this research is to observe how well this medicine works and if it causes any side effects when it's given to adults with advanced Parkinson's disease in France, as part of their routine medical care.

Imagine you're already going to your doctor for Parkinson's treatment. If your doctor decides this medicine, foscarbidopa/foslevodopa, is right for you, then you might be able to join this study. It's not about trying a new, experimental drug, but rather about gathering information on how an approved drug performs in typical patient care. This helps doctors and researchers understand more about the medicine's effects in everyday use.

Key takeaways

This study looks at a Parkinson's medicine called foscarbidopa/foslevodopa in real-life use.
It's for adults in France with advanced Parkinson's disease whose symptoms aren't fully controlled.
You participate if your doctor has already prescribed this medicine to you.
Participation involves no extra visits or procedures beyond your standard care.
The study tracks your progress for up to 12 months via your routine appointments.

Who may be eligible?

To join this study, you must be an adult with advanced Parkinson's disease. This means your current treatments aren't fully controlling your movement problems.

Your doctor must also have decided that the medicine foscarbidopa/foslevodopa is the right treatment for you, based on the standard guidelines in France. The decision to start you on this medication needs to be made by your doctor before you even consider joining the study.

However, some people won't be able to join. If you have any health conditions that mean you shouldn't take foscarbidopa/foslevodopa, or if you have significant memory or thinking problems (specifically, a score below 24 on a common memory test called the Mini-Mental State Exam), then you wouldn't be able to take part.

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 aged 18 or over?
Do you have advanced Parkinson's disease with ongoing movement issues?
Has your doctor in France already decided to prescribe you foscarbidopa/foslevodopa?
Do you not have any health reasons that mean you shouldn't take this specific medicine?
Do you have good memory and thinking abilities (e.g., a memory test score of 24 or higher)?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't have any extra appointments to attend or special tests to undergo beyond what your doctor would normally recommend for your Parkinson's care. You will receive the foscarbidopa/foslevodopa medicine as a continuous infusion under your skin, exactly as your doctor prescribes it. You'll continue to see your doctor at your usual hospital or clinic visits, and these routine check-ups will be used to gather information for the study. The study will track your progress for up to 12 months.

Potential risks and benefits

The main benefit of participating is that you will receive medication your doctor believes is suitable for your advanced Parkinson's disease. As this study observes treatment that is already part of routine care, there are no expected additional risks beyond those associated with your normal medical treatment. You will be closely monitored by your healthcare team during your regular visits. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (33)

Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843
Verified postcode
Strasbourg, France
Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182
Verified postcode
Clermont-Ferrand, France
Hospices Civils De Lyon - Direction Des Affaires Médicales /ID# 266404
Verified postcode
Lyon, France
Hôpital La Timone /ID# 265932
Verified postcode
Marseille, France
CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927
Verified postcode
Saint-Brieuc, France
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 266853
Verified postcode
Besançon, France
CHU Brest /ID# 266405
Verified postcode
Brest, France
Chu de Limoges /Id# 266043
Verified postcode
Limoges, France
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375
Verified postcode
Nîmes, France
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932
Verified postcode
Colmar, France
Centre Hospitalier de Bethune /ID# 265994
Verified postcode
Béthune, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954
Verified postcode
Lille, France

Common questions

What is advanced Parkinson's disease?

It means your Parkinson's symptoms, especially movement problems, are no longer fully controlled by your usual medications.

What is foscarbidopa/foslevodopa?

It's a medicine given as a continuous infusion under the skin, used to help manage Parkinson's symptoms. It's already approved outside the US.

Do I have to live in France to join this study?

Yes, this specific study is for adult participants in France. Your doctor would need to be involved.

Will I get 'new' treatment in this study?

No, you will receive the foscarbidopa/foslevodopa medicine if your doctor has already decided it's the right treatment for you, as part of your normal care.

How long will the study last for me?

You will be followed for up to 12 months, through your regular medical appointments.