Idiopathic Parkinson's disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ROT-TDS 8 mg/24 h
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ROTIGOTINE
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Luye Pharma Switzerland AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
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 (see chapter 13.2.1 of the trial protocol) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson’s disease at the end of the dosing interval • Comparative assessment of patch adhesion properties of the Test and Reference product in patients diagnosed with idiopathic Parkinson’s disease at the end of the dosing interval ;Secondary Objective: • Skin tolerability of Test and Reference based on standardised assessment of Adverse Events of Special Interest • Descriptive characterisation of safety and tolerability of the investigational medicinal products (IMPs) in the trial population ;Primary end point(s): patch adhesion: - two-sided 90% confidence limit for the mean adhesion of Test at the end of the dosing interval - in case the lower boundary of the 90% confidence interval of mean adherence for the Test product at the end of the dosing interval does not lie above 90%: non-inferiority of the Test product to the Reference product by test of the T-R contrast and its two-sided 90% confidence limit - descriptive statistics for test and reference, frequency of patch adhesion scores;Timepoint(s) of evaluation of this end point: after data base lock | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): local tolerability: - descriptive statistics for test and reference, frequency of skin irritation scores safety and tolerability: - descriptive statistics and frequency tables as meaningful ;Timepoint(s) of evaluation of this end point: after data base lock | — |
Countries
Germany
Contacts
Public Contactcontact point
Luye Pharma Switzerland AG
Outcome results
None listed