A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Registration Number
- NCT02230904
- Lead Sponsor
- UCB BIOSCIENCES GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Arm B-A Rotigotine (Test product PR 2.3.1) 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) Treatment Arm A-B Rotigotine (Reference product PR 2.1.1) 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) Treatment Arm A-B Rotigotine (Test product PR 2.3.1) 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) Treatment Arm B-A Rotigotine (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)
- Primary Outcome Measures
Name Time Method 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 Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 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
Name Time Method 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 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 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 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 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 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 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 adhesivenessPatch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 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 Subject 24 Hours After Patch Application for Patch 2 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 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 adhesivenessChange 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 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 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 Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 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.
Trial Locations
- Locations (11)
103
🇩🇪Stuttgart, Germany
102
🇩🇪Karlstadt, Germany
109
🇩🇪Erbach, Germany
101
🇩🇪Köln, Germany
105
🇩🇪Berlin, Germany
106
🇩🇪Aschaffenburg, Germany
107
🇩🇪Böblingen, Germany
111
🇩🇪Düsseldorf, Germany
108
🇩🇪Würzburg, Germany
104
🇩🇪Alzenau, Germany
110
🇩🇪Essen, Germany