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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 56
- Primary Endpoint
- The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sequence A-B
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)
Intervention: Rotigotine transdermal patch (Drug)
Sequence B-A
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)
Intervention: Rotigotine transdermal patch (Drug)
Outcomes
Primary Outcomes
The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)
Time Frame: 2 days of 24 hours patch application
The international patch adhesiveness score
Secondary Outcomes
- Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application(after 24 hours of patch application)
- Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application(after 24 hour of patch application)