Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A DOSE-BLINDED EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF UCB0599 IN STUDY PARTICIPANTS WITH PARKINSON’S DISEASE

This friendly study is looking into a new medicine called UCB0599 for people with Parkinson's disease. It's a follow-on study for people who have already taken part in an earlier trial of this medicine. The main goals are to understand if UCB0599 is safe to use over a long time, how well people tolerate it, and if it continues to be helpful in managing Parkinson's symptoms. Researchers will be comparing the active medicine to a dummy pill (placebo) to truly understand its effects. They'll also use special scans to see if the medicine helps protect the brain cells affected by Parkinson's. If successful, this new medicine could offer a valuable treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

UCB Biopharma

Enrolment target

283

Start

29 Nov 2022

Parkinson’s disease

What is this study about?

You might be interested in a new research study that's looking into a potential new treatment for Parkinson's disease. The study is called an 'extension study' because it involves people who have already participated in an earlier trial for the same medicine. This means researchers already have some initial information about the treatment, but they need to learn more about its long-term effects.

The main purpose of this study is to discover if the new medicine, called UCB0599, is safe and can be tolerated well when taken over a longer period. They also want to see if it continues to help with Parkinson's symptoms and if it can protect certain brain cells that are affected by the condition. To do this, some participants will receive the active medicine, while others will receive a 'placebo', which looks identical but doesn't contain any active drug. This comparison helps researchers understand the true effects of the medicine.

Researchers will use special brain scans, called DaT-SPECT, to monitor changes in the brain over time. They will also keep a close eye on any side effects and how much other Parkinson's medication participants are taking. This detailed information will help determine if UCB0599 could become a new, effective treatment option for people living with Parkinson's disease.

Key takeaways

This study is testing a new medicine (UCB0599) for Parkinson's disease.
It's an 'extension study' for people who have already started taking the medicine in an earlier trial.
The aim is to check the medicine's long-term safety and how well it works.
Special brain scans and regular check-ups will be part of the study.
Participants will receive either the study medicine or a dummy pill.
The study could help find new treatments for Parkinson's disease.

Who may be eligible?

To be considered for this study, you must have Parkinson's disease and have previously taken part in an earlier study for the medicine UCB0599. This study is an extension of that previous trial.

Anyone aged 18 years or older can be considered. The study is open to both men and women.

There might be other specific health requirements or conditions that would mean you can or cannot join. These will be discussed in detail by the study team.

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.

Do you have Parkinson's disease?
Have you participated in a previous study for UCB0599?
Are you 18 years old or older?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine (UCB0599) or a dummy pill (placebo). You wouldn't know which one you are taking, and neither would your study doctor, this is known as 'dose-blinded'. Over the course of the study, you would have regular visits to the clinic for various check-ups. These visits will include health assessments, blood tests, and special brain scans called DaT-SPECT at certain times, like after 18 months. The study team will monitor your general health, any changes in your Parkinson's symptoms, and any side effects you might experience. They will also track any other Parkinson's medicines you are taking. The total duration of your participation in this extension study will be explained in detail.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might benefit from receiving a new medicine that could help manage your Parkinson's disease. However, there's also a chance you could receive the dummy pill and not experience any direct benefit from the study medicine itself. Potential risks include experiencing side effects from the study medicine, or from the brain scans or other procedures. All possible side effects will be fully explained before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Netherlands
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Unverified
Germany
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Unverified
Spain
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Unverified
Italy
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Unverified
Poland
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Unverified
France

Common questions

What is UCB0599?

UCB0599 is a new medicine being investigated for the treatment of Parkinson’s disease.

What is a 'placebo'?

A placebo is a dummy pill or treatment that looks exactly like the study medicine but doesn't contain any active drug.

What is a DaT-SPECT scan?

It's a special type of brain scan that helps doctors see how certain brain cells affected by Parkinson's are working.

What does 'dose-blinded' mean?

It means neither you nor your study doctor will know whether you are receiving the active medicine or the placebo.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can withdraw from the study at any point without it affecting your medical care.