Overview

A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar adhesiveness properties.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB BIOSCIENCES GmbH
Collaborators:
Bracket Global
Pharmaceutical Health Sciences
Treatments:
N 0437
Rotigotine
Criteria
Inclusion Criteria:

- Subject has a diagnosis of idiopathic Parkinson's Disease

- Subject has been on continuous treatment with commercially available Rotigotine
transdermal patches (Neupro®) for at least 3 months prior to enrollment

- Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2)
patch for at least 2 weeks prior to enrollment

Exclusion Criteria:

- Subject has any medical or psychiatric condition which, in the opinion of the
investigator, could jeopardize or would compromise the subject's well-being or ability
to participate in this study

- Subject has a history of significant skin hypersensitivity to adhesives or other
transdermal products or recently unsolved contact dermatitis

- Subject has a history or present condition of an atopic or eczematous Dermatitis,
Psoriasis, or an active skin disease

- Subject has a lifetime history of suicide attempt (including an active attempt,
interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
months as indicated by a positive response ('yes') to either Question 4 or Question 5
of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or
Baseline (Visit 2)