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Rotigotine

Clinical trials of Rotigotine are studying how well it works and how safe it is in different patient groups. The trials include people with Parkinson’s disease, mild to moderate Alzheimer’s disease, and autosomal dominant polycystic kidney disease. They also measure patch adhesion, cognitive outcomes, and safety over time.

Table of Contents

Clinical trials overview

These studies of Rotigotine are testing different research questions in different patient groups.[1][2][3] One study is in people with Parkinson’s disease, one is in people with mild to moderate Alzheimer’s disease, and one is in people with autosomal dominant polycystic kidney disease (ADPKD).[1][2][3]

The trial designs are interventional, which means the researchers give a study treatment and then measure the results.[1][2][3] The studies include Phase 2 and Phase 3 trials, so they range from earlier testing to larger confirmatory research.[1][2][3]

Parkinson’s disease patch-adhesion study

This completed Phase 2 trial studied whether a new Rotigotine patch stayed attached to the skin in people with Parkinson’s disease.[1] The study enrolled 24 participants and compared the test patch with a reference patch product.[1]

The main endpoint was adhesion, which means how well the patch sticks to the skin during the dosing period.[1] The trial measured the mean adhesion of the test patch at 23 hours and 55 minutes, which is almost the end of the wearing time.[1] It also measured the difference in adhesion between the test and reference products at that same time point.[1]

This study was focused on a practical question: whether the patch remains in place for the full dosing interval in real use.[1]

Alzheimer’s disease Phase 3 study

This Phase 3 study is a prospective, randomized, double-blind, placebo-controlled, parallel-group, international, multi-center trial in mild to moderate Alzheimer’s disease.[2] It enrolled 378 participants.[2]

The study is evaluating Rotigotine in combination with rivastigmine and comparing it with rivastigmine plus placebo.[2] In simple terms, the trial is asking whether adding Rotigotine to the background treatment gives better results than not adding it.[2]

The main endpoint is the change from baseline to Week 24 in the FAB, which stands for Frontal Assessment Battery.[2] This is a test of frontal lobe cognitive function, meaning thinking skills such as planning, attention, and decision-making.[2]

The trial uses a placebo, which is an inactive patch that looks like the active one, so the comparison stays fair.[2] The study is authorised, meaning it has approval to proceed.[2]

Kidney disease safety study

This Phase 2 study, called ETERNAL-PKD, is looking at the safety of Rotigotine in patients with autosomal dominant polycystic kidney disease.[3] It is authorised and plans to enroll 120 participants.[3]

The study is evaluating Rotigotine given at 4 mg/24 hours for 24 months, with safety as the main focus.[3] The brief summary says the trial is designed to assess safety in ADPKD over this long follow-up period.[3]

The main safety endpoint is the occurrence of adverse reactions and serious adverse reactions during 24 months of follow-up.[3] The study especially looks at the proportion of participants who have at least one serious adverse reaction, including serious reactions at the application site or certain behavioral disorders.[3]

Main endpoints and what they mean

Clinical trials use endpoints to decide what result matters most.[1][2][3] In these studies, the endpoints are very different because each trial has a different goal.[1][2][3]

  • In Parkinson’s disease, the endpoint is patch adhesion, so the researchers are checking whether the patch stays on the skin as planned.[1]

  • In Alzheimer’s disease, the endpoint is change in FAB score from baseline to Week 24, so the researchers are checking whether thinking skills related to the frontal lobe change over time.[2]

  • In ADPKD, the endpoint is safety over 24 months, especially the number of participants with adverse reactions or serious adverse reactions.[3]

Who the trials are for

The Parkinson’s disease study is for people with Parkinson’s disease, and it focuses on patch performance rather than symptoms alone.[1]

The Alzheimer’s disease study is for people with mild to moderate Alzheimer’s disease and tests whether Rotigotine can add benefit when used with rivastigmine.[2]

The kidney study is for people with ADPKD, a type of kidney disease with many cysts, and it mainly looks at long-term safety.[3]

Together, these trials show that Rotigotine is being studied across different patient groups, with outcomes that match each disease and research question.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollmentMain endpoint
2025-521172-64-00Phase 2Parkinson’s diseaseCompleted24Mean patch adhesion at 23 h 55 min; difference vs reference
2023-504602-11-00Phase 3Mild to moderate Alzheimer’s diseaseAuthorised378Change in FAB from baseline to Week 24
2024-515734-32-00Phase 2Kidney Disease / ADPKDAuthorised120Safety over 24 months; AEs and SAEs

FAQ

  • What are clinical trials of Rotigotine studying? These trials are looking at different research questions, such as skin adhesion of a patch, cognitive effects in Alzheimer’s disease, and safety in kidney disease. They are not all studying the same condition.
  • Who can take part in Rotigotine trials? The target groups in the listed trials are people with Parkinson’s disease, mild to moderate Alzheimer’s disease, and autosomal dominant polycystic kidney disease. Each trial has its own eligibility rules.
  • What trial phases are included? The listed studies include Phase 2 and Phase 3 trials. Phase 2 usually looks more closely at safety and early effectiveness, while Phase 3 compares treatments in larger groups.
  • What outcomes are being measured? The trials measure patch adhesion, change in frontal lobe cognitive function, and safety outcomes such as adverse reactions and serious adverse reactions. Some studies also compare Rotigotine with placebo or a reference patch.
  • Are these trials completed? One Parkinson’s disease patch-adhesion study is completed. The Alzheimer’s disease and kidney disease studies are authorised, which means they are approved to move forward.

Ongoing Clinical Trials on Rotigotine

  • Study on the Safety of Rotigotine for Patients with Autosomal Dominant Polycystic Kidney Disease

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effects of Rotigotine and Rivastigmine in Patients with Mild to Moderate Alzheimer’s Disease

    Recruiting

    3 1 1
    Investigated drugs:
    Czechia Germany Italy Spain

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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Adverse reaction (AE): An unwanted medical problem that happens during a study. It may or may not be caused by the study treatment.
  • Serious adverse reaction (SAE): A more serious unwanted medical problem, such as one that is dangerous, life-threatening, or needs hospital care.
  • Adhesion: How well a patch sticks to the skin during the planned wearing time.
  • Baseline: The starting point before treatment begins. Results are often compared with this starting measurement.
  • Double-blind: A study design where neither the participants nor the researchers know who gets the active treatment or placebo during the trial.
  • Placebo: An inactive treatment that looks like the real treatment. It is used for comparison in some trials.
  • Phase 2: A trial stage that often focuses on safety and early signs of benefit in a smaller group of participants.
  • Phase 3: A later trial stage with a larger group, usually used to compare treatments more fully.
  • Frontal lobe cognitive function: Thinking skills linked to the front part of the brain, such as planning, attention, and decision-making.
  • Autosomal dominant polycystic kidney disease (ADPKD): A kidney disease in which many fluid-filled cysts grow in the kidneys and can affect kidney function.

References

  1. https://clinicaltrials.gov/study/2025-521172-64-00
  2. https://clinicaltrials.gov/study/2023-504602-11-00
  3. https://clinicaltrials.gov/study/2024-515734-32-00