Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Lu AF28996 in Patients With Parkinson's Disease

This research study is about a new potential medicine, known for now as Lu AF28996, for people living with Parkinson's disease. This is a very early study, sometimes called a Phase I study. The main goal at this stage is to carefully check if the medicine is safe and how it behaves in the human body. Researchers will also look for any side effects. It's not yet about whether it can treat Parkinson's, but it's an important first step. The study is open to both men and women aged 18 and older who have Parkinson's disease. If you're interested, your medical team can help you understand more about whether it might be suitable for you.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

H. Lundbeck A/S

Enrolment target

Start

24 May 2024

Parkinson's Disease

What is this study about?

This study is investigating a new medication, currently known as Lu AF28996, for individuals who have Parkinson's disease. Parkinson's is a condition that affects the brain and can cause problems with movement, such as tremors, stiffness, and difficulty with balance.

This particular study is a very early-stage trial, often called a Phase I study. This means that the main purpose is not to see if the medicine can cure or greatly improve Parkinson's symptoms yet. Instead, the doctors and scientists want to carefully understand how this new medicine works in the body, confirm it's safe for people to take, and identify any potential side effects. It's a crucial first step in developing any new treatment.

By taking part in studies like this, volunteers help researchers gather important information that can decide if a new medicine should be tested further in larger studies. This step-by-step process is how all new medicines are developed and approved, and without volunteers, medical progress would not be possible.

Key takeaways

This is an early study of a new medicine (Lu AF28996) for Parkinson's disease.
The main focus is to check the medicine's safety and how it works in the body.
People aged 18 or older with Parkinson's can potentially take part.
Taking part means regular clinic visits and close medical monitoring.
There are potential risks, like side effects, but also the chance to help medical research.
You can withdraw from the study at any time, for any reason.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women are welcome to take part. The exact details of who can join will be carefully checked by the study doctors.

Generally, you would need to have a confirmed diagnosis of Parkinson's disease. There might be some specific health conditions or medications that would prevent someone from joining, as these could potentially affect how the study medicine works or make taking part unsafe. These specific details would be discussed with you by the study team.

It's important to have a chat with your GP or specialist if you're thinking about joining. They can help you understand if this study might be a good fit for you based on your personal health situation.

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 18 years old or older?
Have you been diagnosed with Parkinson's disease?
Are you able to attend regular clinic visits?
Are you willing to take a new, experimental medicine?
Are you comfortable with blood tests and other medical assessments?
Are you able to understand and sign the consent form?

Answer every question to see your result.

What does participation involve?

Taking part in a study like this usually involves several visits to a clinic or hospital over a period of time. You would have regular check-ups, which include physical exams, blood tests, and sometimes other tests to monitor your health and how the medicine is affecting you. You would be given the study medicine (Lu AF28996) according to a specific schedule.

During your visits, the study team would ask you questions about your health and any side effects you might be experiencing. It's very important to attend all scheduled visits and report any changes in your health. After you finish taking the medicine, there might be follow-up visits to ensure your health remains stable. The total length of your involvement in the study would be explained to you in detail by the research team.

Potential risks and benefits

The potential benefits of taking part in an early-stage study like this are primarily to help advance medical understanding and contribute to the development of new treatments for Parkinson's disease. You would also receive close medical attention from the study team. However, it's important to know that there's no guarantee the study medicine will improve your Parkinson's symptoms, as this study is mainly focused on safety. As with any medicine, there is a risk of side effects, which could be mild or, in rare cases, more serious. All known risks would be fully explained before you decide to take part. Remember, joining a study is always voluntary, and you are free to change your mind and withdraw at any time without explaining why, and this will not affect your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
France
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Unverified
Spain

Common questions

What is Parkinson's disease?

Parkinson's disease is a long-term condition that affects the brain. It can cause problems with movement, such as shaking, stiffness, and difficulty with balance and coordination.

What does 'Phase I study' mean?

A Phase I study is a first step in testing a new medicine in people. The main goal is to check if it's safe to use and to understand how it works in the body, rather than to see if it treats the condition yet.

Will I get better if I join this study?

This study is mainly about checking safety, not about whether the medicine treats Parkinson's. While some studies might show improvements, it's not the main goal at this early stage, and there's no guarantee you will feel better.

Will I have to pay to be in the study?

No, you should not have to pay to take part in this study. All study-related care and medication will be provided free of charge.

Can I leave the study at any time?

Yes, taking part is completely voluntary. You can decide to leave the study at any point, for any reason, without it affecting your regular medical care.