Loading clinical trials...

A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease

NCT02230904•UCB BIOSCIENCES GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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)

Locations (11)

104

Alzenau in Unterfranken, Germany

106

Aschaffenburg, Germany

105

Berlin, Germany

107

Böblingen, Germany

101

Cologne, Germany

111

Düsseldorf, Germany

109

Erbach im Odenwald, Germany

110

Essen, Germany

102

Karlstadt am Main, Germany

103

Stuttgart, Germany

Key Dates

Start Date

September 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

December 1, 2014

Last Updated

November 2, 2015

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Rotigotine (Test product PR 2.3.1)

DRUG

Rotigotine (Reference product PR 2.1.1)

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations