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Completed

NCT Number: NCT01338896

Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine transdermal patch

Drug

8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Other names: Neupro

Primary outcomes

  1. 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

  1. Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application

    Time frame: after 24 hours of patch application

    The international patch adhesiveness score

  2. Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application

    Time frame: after 24 hour of patch application

    The international patch adhesiveness score

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 20, 2011
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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