E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Parkinson's disease |
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E.1.1.1 | Medical condition in easily understood language |
Idiopathic Parkinson's disease |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Assessment of patch adhesion and local tolerability |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Following definition in the guidance 2010/C82/01,2.5,43., end of trial has been defined as last patient, last visit. Formal discharge of a patient from the trial after review of all data available from the last visit normally occurs after the last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |