Investigation of the adhesion properties of a newly developed rotigotine-containing patch in patients with Parkinson's disease

Phase 1

• Conditions: Idiopathic Parkinson's disease; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-000867-65-DE
• Lead Sponsor: uye Pharma Switzerland AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-16
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified