Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Pa… (NCT06247410) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease
Germany38 participantsStarted 2021-08-23
Plain-language summary
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product.
It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ethnic origin: Caucasian
. age: 18 years or older
. diagnosis of idiopathic Parkinson's disease
. administration of a stable dose of at least 8 mg/24 h rotigotine including use of an 8 mg/24 h patch for at least 2 weeks prior to enrolment
. agreement to refrain from swimming, bathing or using a sauna on the assessment days
. written informed consent obtained, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
Timeframe: 24 hours
2
Comparative assessment of patch adhesion properties of the Test vs. Reference product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
. existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
. existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson's disease)
. existing and/or history of psoriasis
. existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment
. history of or current drug or alcohol dependence
. existing medical condition or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the patient's well-being or ability to participate in this study