Clinical trial NCT02230904: A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Rotigotine patch
Neupro
Parkinson's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Health Sciences
name: Bracket Global
First posted: 2014-09-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 criteria: 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)

Primary outcomes:
measure: Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline
timeFrame: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
Secondary outcomes:
measure: Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
measure: Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
measure: Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
measure: Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
measure: Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
measure: Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
measure: Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score
timeFrame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
Other outcomes:
Locations:
city: Alzenau
country: Germany
facility: 104
city: Aschaffenburg
country: Germany
facility: 106
city: Berlin
country: Germany
facility: 105
city: Böblingen
country: Germany
facility: 107
city: Düsseldorf
country: Germany
facility: 111
city: Erbach
country: Germany
facility: 109
city: Essen
country: Germany
facility: 110
city: Karlstadt
country: Germany
facility: 102
city: Köln
country: Germany
facility: 101
city: Stuttgart
country: Germany
facility: 103
city: Würzburg
country: Germany
facility: 108
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.