Title
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
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
Phase
Phase 1Lead Sponsor
Hoosier Cancer Research NetworkStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Parkinson's DiseaseIntervention/Treatment
rotigotine ...Study Participants
57The 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.
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
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)
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)
| Event Type | Organ System | Event Term | Treatment A | Treatment B |
|---|
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.
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 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 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.
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.
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
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
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.