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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.

NCT04183634

Parkinson Disease

TERMINATED PHASE1

A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease

NCT00243945

IDIOPATHIC PARKINSON'S DISEASE

COMPLETED PHASE3

A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease

NCT00243971

Parkinson's Disease

COMPLETED PHASE3

Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

NCT00244387

Parkinson Disease, Idiopathic

COMPLETED PHASE3

Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine

NCT00474058

Parkinson's Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence: Reference-Test-Reference-Test (RTRT)

Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with RTRT sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase.

Period 1: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application

Period 2: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application

Period 3: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application

Period 4: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application

Group Type OTHER

Rotigotine 8Mg/24Hrs Patch

Intervention Type DRUG

Once daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days

Sequence: Test-Refrence-Test-Reference

Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with TRTR sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase.

Period 1: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application

Period 2: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application

Period 3: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application

Period 4: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application

Group Type OTHER

Rotigotine 8Mg/24Hrs Patch

Intervention Type DRUG

Once daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rotigotine 8Mg/24Hrs Patch

Once daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No