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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
* Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal
* Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal
104
Alzenau in Unterfranken, Germany
106
Aschaffenburg, Germany
105
Berlin, Germany
107
Böblingen, Germany
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.
Time frame: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
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.
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
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101
Cologne, Germany
111
Düsseldorf, Germany
109
Erbach im Odenwald, Germany
110
Essen, Germany
102
Karlstadt am Main, Germany
103
Stuttgart, Germany
...and 1 more locations
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
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.
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
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.
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
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
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
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
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
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.
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5