Clinical trial to investigate the adherence of a new Rotigotine patch to the skin of patients with Parkinson’s disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Luye Pharma Switzerland AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

5 Jan 2026 → 6 Mar 2026

Decision date (initial)

2025-07-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Luye Pharma Switzerland AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Assessment of skin adhesion properties of Test product at the end of the dosing interval
Comparative assessment of skin adhesion properties of the Test and Reference product at the end of the dosing interval

Secondary objectives 2

1. Skin tolerability of Test and Reference based on standardised assessment of Adverse Events of Special Interest
2. Descriptive characterisation of safety and tolerability of the investigational medicinal products (IMPs) in the trial population

Conditions and MedDRA coding

Parkinson's disease

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Ethnic group: Caucasian
2. Age: 18 years or older
3. Diagnosis of idiopathic Parkinson’s disease
4. Administration of a stable dose of at least 12 mg/24 h rotigotine 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, 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 participants participating in the clinical trial

Exclusion criteria 18

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 participant’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. Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
10. History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
11. Administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the participant
12. Simultaneous participation in another clinical trial with active ingredients
13. Positive pregnancy test at screening examination
14. Pregnant or lactating women
15. Female participants who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol)
16. Participant is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or close affiliation with the sponsor or the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee of or student at the investigational site), employee of sponsor`s affiliates)
17. Participants suspected or known not to follow instructions
18. Participants 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Mean adhesion of Test at 23 h 55 min
2. Difference of adhesiveness (Test – Reference) at 23 h 55 min

Secondary endpoints 2

1. Frequency of AESIs
2. Frequency of AEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Luye Pharma Switzerland AG

Sponsor organisation

Luye Pharma Switzerland AG

Address

Baumleingasse 22

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

Luye Pharma Switzerland AG

Contact name

Director R&D

Public contact point

Organisation

Luye Pharma Switzerland AG

Contact name

Clinical Trial Leader

Third parties 3

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications