A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
NCT ID: NCT02230904
Last Updated: 2015-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2014-09-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment Arm A-B
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)
Rotigotine (Test product PR 2.3.1)
* Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal
Rotigotine (Reference product PR 2.1.1)
* Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal
Treatment Arm B-A
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)
Rotigotine (Test product PR 2.3.1)
* Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal
Rotigotine (Reference product PR 2.1.1)
* Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal
Interventions
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Rotigotine (Test product PR 2.3.1)
* Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal
Rotigotine (Reference product PR 2.1.1)
* Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Pharmaceutical Health Sciences
UNKNOWN
Bracket Global
UNKNOWN
UCB BIOSCIENCES GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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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
108
Würzburg, , Germany
Countries
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References
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Elshoff JP, Bauer L, Goldammer N, Oortgiesen M, Pesch H, Timmermann L. Randomized, double-blind, crossover study of the adhesiveness of two formulations of rotigotine transdermal patch in patients with Parkinson's disease. Curr Med Res Opin. 2018 Jul;34(7):1293-1299. doi: 10.1080/03007995.2018.1430559. Epub 2018 Feb 20.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-000932-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PD0018
Identifier Type: -
Identifier Source: org_study_id
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