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

UCB

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Rotigotine (Reference product PR 2.1.1); Drug: Rotigotine (Test product PR 2.3.1)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02230904

2014-000932-41 (EudraCT Number)

PD0018

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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57 participants in 2 patient groups

Treatment Arm A-B

Experimental group

Description:

4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)

Treatment:

Drug: Rotigotine (Test product PR 2.3.1)

Drug: Rotigotine (Reference product PR 2.1.1)

Treatment Arm B-A

Experimental group

Description:

4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)

Treatment:

Drug: Rotigotine (Test product PR 2.3.1)

Drug: Rotigotine (Reference product PR 2.1.1)