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 range18 Years
SexALL
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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
✕. 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
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 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