Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-09 @ 3:57 PM
Study NCT ID:
NCT02230904
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047508', 'term': 'rotigotine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 887 822 9493', 'title': 'UCB (Study Director)', 'organization': 'UCB Clinical Trial Call Center'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent Adverse Events were collected from Visit 2 (Day 1) up to the Safety Follow-up Visit (Day 12).', 'description': 'Adverse Events refer to the Safety Set, consisting of all randomized subjects who entered the study and received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).', 'otherNumAtRisk': 57, 'otherNumAffected': 7, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).', 'otherNumAtRisk': 57, 'otherNumAffected': 1, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.115', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.635', 'groupDescription': 'The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5', '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).\n\n* 0 = \\> 95 - 100 % of the patch area adheres\n* 1 = \\> 90 - 95 % of the patch adheres\n* 2 = \\> 85 - 90 % of the patch adheres\n* 3 = \\> 80 - 85 % of the patch adheres\n* 4 = \\> 75 - 80 % of the patch adheres\n* 5 = \\> 70 - 75 % of the patch adheres\n* 6 = ≥ 50 - 70 % of the patch adheres\n* 7 = \\< 50 % of the patch adheres\n* 8 = Patch completely detached\n\nThe 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.\n\nThe average of patches 1 and 2 is presented by Treatment Arm below.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'patches', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1'}], 'classes': [{'title': '> 95 %', 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': '> 90 % - 95 %', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': '> 85 % - 90 %', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': '> 80 % - 85 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': '> 75 % - 80 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': '> 70 % - 75 %', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': '<= 70 %', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4', '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).\n\n* 0 = \\>95 - 100 % of the patch area adheres\n* 1 = \\>90 - 95 % of the patch adheres\n* 2 = \\>85 - 90 % of the patch adheres\n* 3 = \\>80 - 85 % of the patch adheres\n* 4 = \\>75 - 80 % of the patch adheres\n* 5 = \\>70 - 75 % of the patch adheres\n* 6 = ≥50 - 70 % of the patch adheres\n* 7 = \\<50 % of the patch adheres\n* 8 = Patch completely detached\n\nThe 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.', 'unitOfMeasure': 'percentage of patches', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patches', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', 'title': 'Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'patches', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1'}], 'classes': [{'title': '> 95 %', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}]}]}, {'title': '> 90 % - 95 %', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': '> 85 % - 90 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': '> 80 % - 85 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': '> 75 % - 80 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': '> 70 % - 75 %', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': '<= 70 %', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '23.1', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5', '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).\n\n* 0 = \\>95 - 100 % of the patch area adheres\n* 1 = \\>90 - 95 % of the patch adheres\n* 2 = \\>85 - 90 % of the patch adheres\n* 3 = \\>80 - 85 % of the patch adheres\n* 4 = \\>75 - 80 % of the patch adheres\n* 5 = \\>70 - 75 % of the patch adheres\n* 6 = ≥50 - 70 % of the patch adheres\n* 7 = \\<50 % of the patch adheres\n* 8 = Patch completely detached\n\nThe 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.', 'unitOfMeasure': 'percentage of patches', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patches', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'patches', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1'}], 'classes': [{'title': '>= 90 %', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '63.5', 'groupId': 'OG001'}]}]}, {'title': '75 % -< 90 %', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': '50 % -< 75 %', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': '< 50 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Detached', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4', '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:\n\n* 0 (\\>95-100% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 1 (\\>90-95% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 2 (\\>85-90% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 3 (\\>80-85% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 4 ( \\>75-80% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 5 (\\>70-75% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 6 (≥50-70% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 7 (\\<50 % of patch adheres) \\>\\> 3 (FDA/CDER)\n* 8 (Patch completely detached) \\>\\> 4 (FDA/CDER)\n\nDue 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.', 'unitOfMeasure': 'percentage of patches', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patches', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'patches', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1'}], 'classes': [{'title': '>= 90 %', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}]}]}, {'title': '75 % -< 90 %', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}]}]}, {'title': '50 % -< 75 %', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': '< 50 %', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Detached', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5', '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:\n\n* 0 (\\>95-100% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 1 (\\>90-95% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 2 (\\>85-90% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 3 (\\>80-85% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 4 ( \\>75-80% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 5 (\\>70-75% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 6 (≥50-70% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 7 (\\<50 % of patch adheres) \\>\\> 3 (FDA/CDER)\n* 8 (Patch completely detached) \\>\\> 4 (FDA/CDER)\n\nDue 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.', 'unitOfMeasure': 'percentage of patches', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patches', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', 'title': 'Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'patches', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1'}], 'classes': [{'title': '0 = Satisfied with adhesiveness', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '65.4', 'groupId': 'OG001'}]}]}, {'title': '1 = Moderately satisfied with adhesiveness', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}]}]}, {'title': '2 = Moderately unsatisfied with adhesiveness', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': '3 = Unsatisfied with adhesiveness', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4', 'description': 'The subject assessed the patch adhesiveness by using the following score:\n\n* 0 = Satisfied with adhesiveness\n* 1 = Moderately satisfied with adhesiveness\n* 2 = Moderately unsatisfied with adhesiveness\n* 3 = Unsatisfied with adhesiveness', 'unitOfMeasure': 'percentage of patches', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patches', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', 'title': 'Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'patches', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1'}], 'classes': [{'title': '0 = Satisfied with adhesiveness', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}]}]}, {'title': '1 = Moderately satisfied with adhesiveness', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}]}]}, {'title': '2 = Moderately unsatisfied with adhesiveness', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': '3 = Unsatisfied with adhesiveness', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5', 'description': 'The subject assessed the patch adhesiveness by using the following score:\n\n* 0 = Satisfied with adhesiveness\n* 1 = Moderately satisfied with adhesiveness\n* 2 = Moderately unsatisfied with adhesiveness\n* 3 = Unsatisfied with adhesiveness', 'unitOfMeasure': 'percentage of patches', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patches', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.442', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.895', 'groupDescription': 'The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5', '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:\n\n* 0 (\\>95-100% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 1 (\\>90-95% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 2 (\\>85-90% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 3 (\\>80-85% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 4 ( \\>75-80% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 5 (\\>70-75% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 6 (≥50-70% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 7 (\\<50 % of patch adheres) \\>\\> 3 (FDA/CDER)\n* 8 (Patch completely detached) \\>\\> 4 (FDA/CDER)\n\nDue 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm A-B', 'description': '4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)'}, {'id': 'FG001', 'title': 'Treatment Arm B-A', 'description': '4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Safety follow up could not take place', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study started to enroll subjects in September 2014 in Germany and concluded in December 2014.', 'preAssignmentDetails': 'Participant Flow refers to the Randomized Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm A-B', 'description': '4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)'}, {'id': 'BG001', 'title': 'Treatment Arm B-A', 'description': '4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)'}, {'id': 'BG002', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '69.6', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics refer to the Safety Set, consisting of all randomized subjects who entered the study and received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2014-08-29', 'resultsFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-01', 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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).\n\n* 0 = \\> 95 - 100 % of the patch area adheres\n* 1 = \\> 90 - 95 % of the patch adheres\n* 2 = \\> 85 - 90 % of the patch adheres\n* 3 = \\> 80 - 85 % of the patch adheres\n* 4 = \\> 75 - 80 % of the patch adheres\n* 5 = \\> 70 - 75 % of the patch adheres\n* 6 = ≥ 50 - 70 % of the patch adheres\n* 7 = \\< 50 % of the patch adheres\n* 8 = Patch completely detached\n\nThe 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.\n\nThe average of patches 1 and 2 is presented by Treatment Arm below.'}], 'secondaryOutcomes': [{'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', '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).\n\n* 0 = \\>95 - 100 % of the patch area adheres\n* 1 = \\>90 - 95 % of the patch adheres\n* 2 = \\>85 - 90 % of the patch adheres\n* 3 = \\>80 - 85 % of the patch adheres\n* 4 = \\>75 - 80 % of the patch adheres\n* 5 = \\>70 - 75 % of the patch adheres\n* 6 = ≥50 - 70 % of the patch adheres\n* 7 = \\<50 % of the patch adheres\n* 8 = Patch completely detached\n\nThe 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.'}, {'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', '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).\n\n* 0 = \\>95 - 100 % of the patch area adheres\n* 1 = \\>90 - 95 % of the patch adheres\n* 2 = \\>85 - 90 % of the patch adheres\n* 3 = \\>80 - 85 % of the patch adheres\n* 4 = \\>75 - 80 % of the patch adheres\n* 5 = \\>70 - 75 % of the patch adheres\n* 6 = ≥50 - 70 % of the patch adheres\n* 7 = \\<50 % of the patch adheres\n* 8 = Patch completely detached\n\nThe 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.'}, {'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', '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:\n\n* 0 (\\>95-100% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 1 (\\>90-95% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 2 (\\>85-90% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 3 (\\>80-85% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 4 ( \\>75-80% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 5 (\\>70-75% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 6 (≥50-70% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 7 (\\<50 % of patch adheres) \\>\\> 3 (FDA/CDER)\n* 8 (Patch completely detached) \\>\\> 4 (FDA/CDER)\n\nDue 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.'}, {'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', '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:\n\n* 0 (\\>95-100% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 1 (\\>90-95% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 2 (\\>85-90% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 3 (\\>80-85% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 4 ( \\>75-80% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 5 (\\>70-75% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 6 (≥50-70% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 7 (\\<50 % of patch adheres) \\>\\> 3 (FDA/CDER)\n* 8 (Patch completely detached) \\>\\> 4 (FDA/CDER)\n\nDue 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.'}, {'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', 'description': 'The subject assessed the patch adhesiveness by using the following score:\n\n* 0 = Satisfied with adhesiveness\n* 1 = Moderately satisfied with adhesiveness\n* 2 = Moderately unsatisfied with adhesiveness\n* 3 = Unsatisfied with adhesiveness'}, {'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', 'description': 'The subject assessed the patch adhesiveness by using the following score:\n\n* 0 = Satisfied with adhesiveness\n* 1 = Moderately satisfied with adhesiveness\n* 2 = Moderately unsatisfied with adhesiveness\n* 3 = Unsatisfied with adhesiveness'}, {'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', '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:\n\n* 0 (\\>95-100% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 1 (\\>90-95% of patch adheres) \\>\\> 0 (FDA/CDER)\n* 2 (\\>85-90% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 3 (\\>80-85% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 4 ( \\>75-80% of patch adheres) \\>\\> 1 (FDA/CDER)\n* 5 (\\>70-75% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 6 (≥50-70% of patch adheres) \\>\\> 2 (FDA/CDER)\n* 7 (\\<50 % of patch adheres) \\>\\> 3 (FDA/CDER)\n* 8 (Patch completely detached) \\>\\> 4 (FDA/CDER)\n\nDue 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotigotine patch', 'Neupro', "Parkinson's Disease"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '29461870', 'type': 'DERIVED', '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."}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a diagnosis of idiopathic Parkinson's Disease\n* Subject has been on continuous treatment with commercially available Rotigotine transdermal patches (Neupro®) for at least 3 months prior to enrollment\n* 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\n\nExclusion Criteria:\n\n* 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\n* Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis\n* Subject has a history or present condition of an atopic or eczematous Dermatitis, Psoriasis, or an active skin disease\n* 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)"}, 'identificationModule': {'nctId': 'NCT02230904', 'briefTitle': "A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'PD0018'}, 'secondaryIdInfos': [{'id': '2014-000932-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm A-B', '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)', 'interventionNames': ['Drug: Rotigotine (Test product PR 2.3.1)', 'Drug: Rotigotine (Reference product PR 2.1.1)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm B-A', '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)', 'interventionNames': ['Drug: Rotigotine (Test product PR 2.3.1)', 'Drug: Rotigotine (Reference product PR 2.1.1)']}], 'interventions': [{'name': 'Rotigotine (Test product PR 2.3.1)', 'type': 'DRUG', 'description': '* Pharmaceutical form: Transdermal patch\n* Concentration: 8 mg/24 hours\n* Route of administration: Transdermal', 'armGroupLabels': ['Treatment Arm A-B', 'Treatment Arm B-A']}, {'name': 'Rotigotine (Reference product PR 2.1.1)', 'type': 'DRUG', 'otherNames': ['Neupro'], 'description': '* Pharmaceutical form: Transdermal patch\n* Concentration: 8 mg/24 hours\n* Route of administration: Transdermal', 'armGroupLabels': ['Treatment Arm A-B', 'Treatment Arm B-A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alzenau in Unterfranken', 'country': 'Germany', 'facility': '104', 'geoPoint': {'lat': 50.0888, 'lon': 9.06455}}, {'city': 'Aschaffenburg', 'country': 'Germany', 'facility': '106', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '105', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Böblingen', 'country': 'Germany', 'facility': '107', 'geoPoint': {'lat': 48.68212, 'lon': 9.01171}}, {'city': 'Cologne', 'country': 'Germany', 'facility': '101', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': '111', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Erbach im Odenwald', 'country': 'Germany', 'facility': '109', 'geoPoint': {'lat': 49.66148, 'lon': 8.99402}}, {'city': 'Essen', 'country': 'Germany', 'facility': '110', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Karlstadt am Main', 'country': 'Germany', 'facility': '102', 'geoPoint': {'lat': 49.96034, 'lon': 9.77239}}, {'city': 'Stuttgart', 'country': 'Germany', 'facility': '103', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': '108', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB BIOSCIENCES GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pharmaceutical Health Sciences', 'class': 'UNKNOWN'}, {'name': 'Bracket Global', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}