Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants with Early Idiopathic Parkinson’s Disease

This study is for people who have recently been diagnosed with Parkinson's disease, called 'early idiopathic Parkinson’s disease.' Doctors are testing a new medicine, RO7486967, for the very first time in people. The main goals are to find out if the medicine is safe and if people can tolerate it well. They also want to understand how the medicine moves through the body and starts to work. By doing this early-stage research, called Phase 1, scientists hope to learn important information that could lead to new ways to help people with Parkinson's in the future. It’s an important step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

22 Aug 2023

Early Idiopathic Parkinson’s Disease (PD)

What is this study about?

Parkinson's disease is a condition that affects how we move. Our bodies have special messengers called dopamine, and in Parkinson’s, some cells that make dopamine die off. This causes symptoms like shaking, stiffness, and slow movement. Scientists are always looking for new ways to help manage these symptoms and hopefully slow down or stop the disease from getting worse.

This particular study is focusing on a new medicine called RO7486967. Think of it as a very early test drive for this medicine. It's the first time it’s being given to people, specifically those who have recently been diagnosed with Parkinson's. The main aim isn't to cure the disease at this stage, but to gather really important information.

The researchers want to learn several things: Is this new medicine safe for people? Does it cause any serious side effects? How does the body absorb, use, and get rid of the medicine? And does it have any noticeable effects on the body? All this information is crucial for deciding if the medicine should be studied further in larger groups of people. It’s a vital step in discovering new treatments.

Key takeaways

This is an early-stage study (Phase 1) for a new Parkinson's medicine.
It's for people with recently diagnosed (early) Parkinson’s disease.
The main goals are to check the medicine's safety and how the body handles it.
It aims to gather vital information for future Parkinson's treatments.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Importantly, you must have what doctors call 'early idiopathic Parkinson’s disease.' 'Early' means you were diagnosed recently, and 'idiopathic' is the most common type of Parkinson’s disease, where the cause isn't known. If your Parkinson's was caused by something specific (like head injury or certain medicines), you likely wouldn't be eligible.

There might be other health requirements too, such as not having other serious health conditions, or not taking certain medications that could interfere with the study drug. The study team will check all these carefully to make sure it's safe for you 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 18 years old or older?
Have you been diagnosed with Parkinson's disease?
Is your Parkinson’s considered 'early' or recently diagnosed?
Has your doctor told you that your Parkinson's is 'idiopathic' (meaning, the cause is unknown)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, RO7486967. Because this is an early-stage study, you would come to the clinic for various appointments. These visits would likely involve medical checks, blood tests, and other assessments to monitor your health and see how you react to the medicine. The research team would explain all the specific tests and visits in detail.

The total duration of your involvement in the study, including how many visits you would need to make and over what period, would be fully explained before you agree to participate. There would also be follow-up appointments after you stop taking the medicine to make sure you are doing well.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would be among the first to receive a new medicine that could potentially help with Parkinson's disease. You would also contribute valuable information that could lead to better treatments for others in the future. However, there's no guarantee the medicine will help you, or that it will be beneficial in the long run. Potential risks include experiencing side effects from the new medicine, which could be mild or, in rare cases, serious. The research team will carefully monitor you for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What does 'idiopathic Parkinson’s disease' mean?

It's the most common type of Parkinson’s disease, where the cause is not yet known.

What does 'Phase I' mean for a study?

It means this is one of the first times the new medicine is being tested in people. It mainly checks for safety and how the body handles the medicine.

Will I definitely get better if I join this study?

Not necessarily. The main aim of this early study is to check safety. There's no guarantee the medicine will improve your Parkinson's symptoms.

How long will I have to be in the study if I join?

The exact length would be explained by the study team. It typically involves several visits over a period, plus follow-up after the medicine stops.

Can I stop taking part in the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time without any reason, and it won't affect your medical care.