Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease

Comparative, Randomized, Open, Crossover Clinical Trial to Investigate Adhesiveness of a Newly Developed Rotigotine-containing Transdermal Patch in Patients With Parkinson's Disease

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.

This multi-centre, open, randomized (order of treatments), multiple dose trial will be performed in a 4-period, 2-sequence-crossover design. A washout phase is not needed, i.e. the IMP application of the 2nd study period may take place the day of the IMP removal of the 1st study period (direct switch-over) and so forth.

Patients with a diagnosis of idiopathic Parkinson's disease and a continuous and stable dose of rotigotine (at least 8 mg/24 h) including use of an 8 mg/24 hours patch will be randomized.

In each of the 4 periods 1 patch, either of Test or Reference will be applied, with a release rate of 8 mg/24 h rotigotine each. Each patch will remain applied for 24 h.

Assessment of patch adhesion will be performed 5 min after application of each patch as well as at the end of the application interval prior to removal of the patch.

The clinical trial will be performed as a crossover investigation with intra-individual comparison, thus reducing variability of the patch adhesion parameters, which is supposed to be higher between patients than within an individual patient.

The patients will continue their usual medications and will only replace one 8 mg/24 h rotigotine containing patch per day with the IMPs for the duration of treatment in the clinical trial. In case of prescribed doses above 8 mg/24 h rotigotine, the remaining dose will be provided by Non-Investigational Medicinal Pproducts (NIMPs). Thus, no interruption in the prescribed dose of rotigotine will occur.

Inclusion Criteria:

1. ethnic origin: Caucasian
2. age: 18 years or older
3. diagnosis of idiopathic Parkinson's disease
4. 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
5. agreement to refrain from swimming, bathing or using a sauna on the assessment days
6. 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:

Safety concerns

1. existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products

2. existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson's disease)

3. existing and/or history of psoriasis

4. existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment

5. history of or current drug or alcohol dependence

6. 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

7. lifetime history of suicide attempt

8. suicidal ideation in the past 6 months

9. administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the patient

10. diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the patient

11. contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the patient

12. known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient

    For female patients with childbearing potential only:

13. positive pregnancy test at screening examination

14. pregnant or lactating women

15. female patients who do not agree to apply highly effective contraceptive methods

    Administrative reasons

16. patients suspected or known not to follow instructions

17. patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial