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Comparing Skin Adhesiveness of a New Rotigotine 12 mg/24 h Transdermal Patch Versus Standard Treatment in Patients with Parkinson's Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is investigating the skin adhesion properties of a newly developed Rotigotine 12 mg/24 h transdermal patch compared to a reference product in patients with Parkinson's disease. Parkinson's disease is a progressive neurological disorder that affects movement, causing tremors, stiffness, and difficulty with balance and coordination. Rotigotine is a medication used to treat symptoms of Parkinson's disease by delivering the medication through a patch that sticks to the skin and releases the drug continuously over 24 hours.

The purpose of this study is to compare how well the new Rotigotine patch adheres to the skin compared to the currently available patch. This is important because proper adhesion ensures consistent delivery of medication. The study has a crossover design, meaning that participants will try both the test patch and the reference patch at different times during the study, allowing for direct comparison between the two products.

During the trial, participants will wear each type of patch, and researchers will assess how well the patches remain attached to the skin near the end of the wearing period (after almost 24 hours). The study will also monitor any adverse events (unwanted side effects) that might occur during the use of either patch. Participants will need to avoid activities like swimming, bathing, or using saunas on assessment days as these could affect how well the patches stick to the skin.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Patch Application
After joining the trial, you will be assigned to start with either the new rotigotine patch (Test product) or the standard Neupro 8 mg/24 h transdermal patch (Reference product).
The patch will be applied to your skin. Both patches contain rotigotine, a medication used to treat Parkinson's disease symptoms.
You must already be using a stable dose of at least 12 mg/24 h of rotigotine for at least 2 weeks before starting the trial.
Step 2
Wearing the First Patch
You will wear the first assigned patch for approximately 24 hours.
During this time, you should avoid swimming, bathing, or using a sauna, especially on assessment days.
The patch should remain attached to your skin throughout the entire 24-hour period.
Step 3
First Assessment Period
After nearly 24 hours (specifically at 23 hours and 55 minutes), a healthcare professional will examine how well the patch has adhered to your skin.
They will assess and record the adhesion properties of the patch, checking if it has remained properly attached or if there has been any lifting or detachment.
Step 4
Crossover to Second Patch
After completing the assessment of the first patch, you will switch to the other patch type (if you started with the Test product, you'll now use the Reference product, or vice versa).
This is known as a crossover design, allowing you to try both patch types during the trial.
Step 5
Wearing the Second Patch
You will wear the second patch for approximately 24 hours, following the same instructions as with the first patch.
The same restrictions apply regarding swimming, bathing, and sauna use.
Step 6
Second Assessment Period
After nearly 24 hours with the second patch, another assessment will be conducted to evaluate its adhesion properties.
The healthcare team will compare how well both patches adhered to your skin during the 24-hour periods.
Step 7
Monitoring for Side Effects
Throughout the trial, the healthcare team will monitor and record any adverse events (AEs) you experience. These are any unfavorable or unintended signs, symptoms, or diseases that occur during the trial.
They will also specifically track adverse events of special interest (AESIs), which are particular side effects they are especially concerned about monitoring.
Step 8
Trial Completion
The trial is expected to run until October 15, 2025, with final results available by December 15, 2025.
After completing both patch assessments and any follow-up evaluations, your participation in the trial will be complete.

Who can join the trial?

6 criteria

You must be 18 years or older
You must be Caucasian (white European descent)
You must have idiopathic Parkinson's disease (Parkinson's disease without a known specific cause)
You must be taking a stable dose of at least 12 mg/24 h rotigotine (a medication delivered through a skin patch) for at least 2 weeks before joining the study
You must agree not to swim, bathe or use a sauna on the days when assessments are conducted
You must provide written informed consent after being told about the benefits and potential risks of the clinical trial, as well as details about the insurance coverage for study participants

Who cannot join the trial?

12 criteria

You cannot join if you are younger than 30 years or older than 80 years.
You cannot join if you are pregnant, planning to become pregnant, or breastfeeding.
You cannot join if you have significant dermatological conditions (skin diseases) that might affect the study results.
You cannot join if you have a history of allergic reactions to transdermal patches (medication patches applied to skin) or any components of the study patches.
You cannot join if you have active skin lesions, scars, tattoos, or significant hair on the areas where patches would be applied.
You cannot join if you are currently participating in another clinical trial or have participated in one within the past 30 days.
You cannot join if you have a history of drug or alcohol abuse within the past year.
You cannot join if you have significant heart, liver, kidney, or other major organ dysfunction.
You cannot join if you are taking medications that might interfere with the study drug.
You cannot join if you are unable to follow the study procedures or attend all required visits.
You cannot join if you have dyskinesia (uncontrollable, involuntary movements) that would interfere with patch application or assessment.
You cannot join if you've had deep brain stimulation (a surgical treatment for Parkinson's) or other surgical treatments for Parkinson's disease.

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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
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Ulm, Germany

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Investigated drugs

Rotigotine is a medication delivered through a transdermal patch (a patch that sticks to your skin) used to treat Parkinson's disease. It works by mimicking the effects of dopamine, a natural substance in the brain that helps control movement and is lacking in people with Parkinson's disease. The patch releases the medication continuously through the skin into the bloodstream over 24 hours.

Rotigotine

What is already known about the treatment

Rotigotine – A medication delivered as a transdermal patch that slowly releases the active ingredient through the skin over 24 hours, providing consistent symptom control for Parkinson's disease patients. Rotigotine belongs to the dopamine agonist class of drugs, which work by stimulating dopamine receptors in the brain to help improve motor function, tremors, and stiffness associated with Parkinson's disease. The patch is typically applied once daily to clean, dry skin, with rotation of application sites recommended to prevent skin irritation. Rotigotine is FDA-approved and well-established in medical literature as an effective treatment option for both early and advanced stages of Parkinson's disease, with the 12 mg/24 h dose typically used for moderate to severe symptoms.

Investigated diseases

Parkinson's disease – A progressive neurological disorder that affects movement, characterized by tremors, muscle rigidity, bradykinesia (slowness of movement), and impaired balance and coordination. The disease occurs when nerve cells in the brain that produce dopamine become impaired or die, leading to a decrease in dopamine levels. As the disease progresses, patients may experience difficulty with walking, talking, and completing simple tasks. Non-motor symptoms can include depression, cognitive changes, sleep problems, and sensory abnormalities. Parkinson's disease typically develops gradually, with symptoms worsening over time as more dopamine-producing cells are lost.