Status:
COMPLETED
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
Lead Sponsor:
UCB BIOSCIENCES GmbH
Collaborating Sponsors:
Pharmaceutical Health Sciences
Bracket Global
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 formula...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02230904
Start Date
September 1 2014
End Date
December 1 2014
Last Update
November 2 2015
Active Locations (11)
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1
104
Alzenau in Unterfranken, Germany
2
106
Aschaffenburg, Germany
3
105
Berlin, Germany
4
107
Böblingen, Germany