Overview

Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma
Treatments:
N 0437
Rotigotine
Criteria
Inclusion Criteria:

- Subjects with a diagnosis of idiopathic ParkinsonĀ“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