Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Rotigotine transdermal patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment Exclusion Criteria: Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A-B<br>4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1) | Drug: Rotigotine transdermal patch<br>* 8 mg/24 h, transdermal patch 8 mg/24 h, 2 days<br>* Other names: Neupro;|
| Experimental: Sequence B-A<br>4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1) | Drug: Rotigotine transdermal patch<br>* 8 mg/24 h, transdermal patch 8 mg/24 h, 2 days<br>* Other names: Neupro;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee) | The international patch adhesiveness score | 2 days of 24 hours patch application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application | The international patch adhesiveness score | after 24 hours of patch application | 
| Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application | The international patch adhesiveness score | after 24 hour of patch application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotigotine, Neupro