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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Rotigotine (Test product PR 2.3.1)
Rotigotine (Reference product PR 2.1.1)
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Rotigotine patch, Neupro, Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • 104
  • 106
  • 105
  • 107
  • 111
  • 109
  • 110
  • 102
  • 101
  • 103
  • 108

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm A-B

Treatment Arm B-A

Arm 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)

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)

Outcomes

Primary Outcome Measures

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
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). 0 = > 95 - 100 % of the patch area adheres 1 = > 90 - 95 % of the patch adheres 2 = > 85 - 90 % of the patch adheres 3 = > 80 - 85 % of the patch adheres 4 = > 75 - 80 % of the patch adheres 5 = > 70 - 75 % of the patch adheres 6 = ≥ 50 - 70 % of the patch adheres 7 = < 50 % of the patch adheres 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline. The average of patches 1 and 2 is presented by Treatment Arm below.

Secondary Outcome Measures

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
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). 0 = >95 - 100 % of the patch area adheres 1 = >90 - 95 % of the patch adheres 2 = >85 - 90 % of the patch adheres 3 = >80 - 85 % of the patch adheres 4 = >75 - 80 % of the patch adheres 5 = >70 - 75 % of the patch adheres 6 = ≥50 - 70 % of the patch adheres 7 = <50 % of the patch adheres 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). 0 = >95 - 100 % of the patch area adheres 1 = >90 - 95 % of the patch adheres 2 = >85 - 90 % of the patch adheres 3 = >80 - 85 % of the patch adheres 4 = >75 - 80 % of the patch adheres 5 = >70 - 75 % of the patch adheres 6 = ≥50 - 70 % of the patch adheres 7 = <50 % of the patch adheres 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
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
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: 0 (>95-100% of patch adheres) >> 0 (FDA/CDER) 1 (>90-95% of patch adheres) >> 0 (FDA/CDER) 2 (>85-90% of patch adheres) >> 1 (FDA/CDER) 3 (>80-85% of patch adheres) >> 1 (FDA/CDER) 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER) 5 (>70-75% of patch adheres) >> 2 (FDA/CDER) 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER) 7 (<50 % of patch adheres) >> 3 (FDA/CDER) 8 (Patch completely detached) >> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
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
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: 0 (>95-100% of patch adheres) >> 0 (FDA/CDER) 1 (>90-95% of patch adheres) >> 0 (FDA/CDER) 2 (>85-90% of patch adheres) >> 1 (FDA/CDER) 3 (>80-85% of patch adheres) >> 1 (FDA/CDER) 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER) 5 (>70-75% of patch adheres) >> 2 (FDA/CDER) 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER) 7 (<50 % of patch adheres) >> 3 (FDA/CDER) 8 (Patch completely detached) >> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
The subject assessed the patch adhesiveness by using the following score: 0 = Satisfied with adhesiveness 1 = Moderately satisfied with adhesiveness 2 = Moderately unsatisfied with adhesiveness 3 = Unsatisfied with adhesiveness
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
The subject assessed the patch adhesiveness by using the following score: 0 = Satisfied with adhesiveness 1 = Moderately satisfied with adhesiveness 2 = Moderately unsatisfied with adhesiveness 3 = Unsatisfied with adhesiveness
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
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: 0 (>95-100% of patch adheres) >> 0 (FDA/CDER) 1 (>90-95% of patch adheres) >> 0 (FDA/CDER) 2 (>85-90% of patch adheres) >> 1 (FDA/CDER) 3 (>80-85% of patch adheres) >> 1 (FDA/CDER) 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER) 5 (>70-75% of patch adheres) >> 2 (FDA/CDER) 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER) 7 (<50 % of patch adheres) >> 3 (FDA/CDER) 8 (Patch completely detached) >> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.

Full Information

First Posted
August 29, 2014
Last Updated
October 1, 2015
Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Pharmaceutical Health Sciences, Bracket Global
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1. Study Identification

Unique Protocol Identification Number
NCT02230904
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Pharmaceutical Health Sciences, Bracket Global

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Rotigotine patch, Neupro, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A-B
Arm Type
Experimental
Arm 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)
Arm Title
Treatment Arm B-A
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Rotigotine (Test product PR 2.3.1)
Intervention Description
Pharmaceutical form: Transdermal patch Concentration: 8 mg/24 hours Route of administration: Transdermal
Intervention Type
Drug
Intervention Name(s)
Rotigotine (Reference product PR 2.1.1)
Other Intervention Name(s)
Neupro
Intervention Description
Pharmaceutical form: Transdermal patch Concentration: 8 mg/24 hours Route of administration: Transdermal
Primary Outcome Measure Information:
Title
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
Description
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). 0 = > 95 - 100 % of the patch area adheres 1 = > 90 - 95 % of the patch adheres 2 = > 85 - 90 % of the patch adheres 3 = > 80 - 85 % of the patch adheres 4 = > 75 - 80 % of the patch adheres 5 = > 70 - 75 % of the patch adheres 6 = ≥ 50 - 70 % of the patch adheres 7 = < 50 % of the patch adheres 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline. The average of patches 1 and 2 is presented by Treatment Arm below.
Time Frame
Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
Secondary Outcome Measure Information:
Title
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
Description
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). 0 = >95 - 100 % of the patch area adheres 1 = >90 - 95 % of the patch adheres 2 = >85 - 90 % of the patch adheres 3 = >80 - 85 % of the patch adheres 4 = >75 - 80 % of the patch adheres 5 = >70 - 75 % of the patch adheres 6 = ≥50 - 70 % of the patch adheres 7 = <50 % of the patch adheres 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Title
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
Description
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). 0 = >95 - 100 % of the patch area adheres 1 = >90 - 95 % of the patch adheres 2 = >85 - 90 % of the patch adheres 3 = >80 - 85 % of the patch adheres 4 = >75 - 80 % of the patch adheres 5 = >70 - 75 % of the patch adheres 6 = ≥50 - 70 % of the patch adheres 7 = <50 % of the patch adheres 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Title
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
Description
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: 0 (>95-100% of patch adheres) >> 0 (FDA/CDER) 1 (>90-95% of patch adheres) >> 0 (FDA/CDER) 2 (>85-90% of patch adheres) >> 1 (FDA/CDER) 3 (>80-85% of patch adheres) >> 1 (FDA/CDER) 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER) 5 (>70-75% of patch adheres) >> 2 (FDA/CDER) 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER) 7 (<50 % of patch adheres) >> 3 (FDA/CDER) 8 (Patch completely detached) >> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Title
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
Description
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: 0 (>95-100% of patch adheres) >> 0 (FDA/CDER) 1 (>90-95% of patch adheres) >> 0 (FDA/CDER) 2 (>85-90% of patch adheres) >> 1 (FDA/CDER) 3 (>80-85% of patch adheres) >> 1 (FDA/CDER) 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER) 5 (>70-75% of patch adheres) >> 2 (FDA/CDER) 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER) 7 (<50 % of patch adheres) >> 3 (FDA/CDER) 8 (Patch completely detached) >> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Title
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
Description
The subject assessed the patch adhesiveness by using the following score: 0 = Satisfied with adhesiveness 1 = Moderately satisfied with adhesiveness 2 = Moderately unsatisfied with adhesiveness 3 = Unsatisfied with adhesiveness
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Title
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
Description
The subject assessed the patch adhesiveness by using the following score: 0 = Satisfied with adhesiveness 1 = Moderately satisfied with adhesiveness 2 = Moderately unsatisfied with adhesiveness 3 = Unsatisfied with adhesiveness
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Title
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
Description
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: 0 (>95-100% of patch adheres) >> 0 (FDA/CDER) 1 (>90-95% of patch adheres) >> 0 (FDA/CDER) 2 (>85-90% of patch adheres) >> 1 (FDA/CDER) 3 (>80-85% of patch adheres) >> 1 (FDA/CDER) 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER) 5 (>70-75% of patch adheres) >> 2 (FDA/CDER) 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER) 7 (<50 % of patch adheres) >> 3 (FDA/CDER) 8 (Patch completely detached) >> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Time Frame
Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
104
City
Alzenau
Country
Germany
Facility Name
106
City
Aschaffenburg
Country
Germany
Facility Name
105
City
Berlin
Country
Germany
Facility Name
107
City
Böblingen
Country
Germany
Facility Name
111
City
Düsseldorf
Country
Germany
Facility Name
109
City
Erbach
Country
Germany
Facility Name
110
City
Essen
Country
Germany
Facility Name
102
City
Karlstadt
Country
Germany
Facility Name
101
City
Köln
Country
Germany
Facility Name
103
City
Stuttgart
Country
Germany
Facility Name
108
City
Würzburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29461870
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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