Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed Rotigotine 12 mg/24 h transdermal patch in patients with Parkinson’s disease

This research study is comparing how well a new patch for Parkinson's disease sticks to the skin against a patch that's already available. Both patches deliver a medicine called Rotigotine, which helps manage Parkinson's symptoms. The main thing researchers want to find out is how firmly the new patch stays on the skin after almost a full day. This is an early phase study, meaning it’s one of the first steps in testing a new treatment. They will also be looking at any side effects people might experience. This helps ensure that any new treatment is not only effective but also comfortable and practical for people to use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Luye Pharma Switzerland AG

Enrolment target

Start

23 Jul 2025

Parkinson's disease

What is this study about?

This study is a clinical trial that aims to understand how well a new skin patch for Parkinson's disease sticks to the skin. People with Parkinson's disease often use patches that release medication slowly through the skin to help manage their symptoms. This new patch contains a medicine called Rotigotine, which is already used in other patches available today. The researchers want to see if this new design of the Rotigotine patch stays on the skin just as well, or even better, than an existing patch for nearly 24 hours.

Think of it like testing if a new type of plaster sticks reliably. For a medication patch to work properly, it needs to stay securely on the skin for the whole time it's meant to deliver medicine. If it peels off, you might not get the full dose of medicine.

This is an early-stage study, sometimes called a Phase II trial. This means it's one of the first human studies of this specific patch design. The information gathered from this study will be used to help develop the patch further, making sure it's reliable and comfortable for people living with Parkinson's disease.

Key takeaways

Tests how well a new Parkinson's patch sticks to the skin.
Compares it to an existing patch that delivers the same medicine.
Aims to improve treatment delivery for people with Parkinson's.
Involves adults (18+) with a Parkinson's diagnosis.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, so older adults are welcome to take part too.

Both men and women can participate in this research. The study is specifically for people who have been diagnosed with Parkinson's disease.

There might be other specific medical requirements or conditions that would mean you can't join, but generally, if you're an adult with Parkinson's, you could be considered.

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?
Do you have a diagnosis of Parkinson's disease?
Are you able to attend clinic visits regularly?
Are you comfortable trying different types of medication patches?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the study clinic at different times. During these visits, you would wear the patches on your skin. The study is designed as a 'crossover' trial, which means you might try the new patch at one time and the existing patch at another. This allows researchers to compare them directly in the same person.

During your visits, the research team would carefully check how well the patches are sticking to your skin, especially after almost a full day (23 hours and 55 minutes). They will also ask you about how you are feeling and if you have experienced any side effects. The total length of your involvement in the study will depend on the specific plan set by the researchers, but it will involve a series of visits to try each patch type and be monitored.

Potential risks and benefits

Taking part in this study could offer some benefits, such as contributing valuable information that helps improve treatment options for people with Parkinson's disease. You would also receive close medical attention during the study period. However, as with any medical study, there are potential risks. You might experience side effects from the patches or the medication, such as skin irritation at the patch site. The patches might also not stick as well as needed, which could affect the amount of medication you receive. You are always free to leave 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
Germany

Common questions

What is the purpose of this study?

This study is looking at how well a new Parkinson's disease patch sticks to the skin compared to an existing one.

What is Rotigotine?

Rotigotine is a medicine in patch form used to help manage symptoms of Parkinson's disease.

Who can join this study?

Adults aged 18 and over, both men and women, who have Parkinson's disease can be considered for this study.

Will I know if I'm getting the new patch or the old one?

This is an 'open' study, so you and the study team will know which patch you are using at each point in the trial.

How long will I need to be in the study?

The total duration of your participation will involve several visits spread over a period, allowing you to try each type of patch and be assessed.