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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230904
• Other study ID #: PD0018
• Secondary ID: 2014-000932-41
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2014
• Last updated: October 1, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rotigotine (Test product PR 2.3.1)
Pharmaceutical form: Transdermal patch Concentration: 8 mg/24 hours Route of administration: Transdermal
• Rotigotine (Reference product PR 2.1.1)
Pharmaceutical form: Transdermal patch Concentration: 8 mg/24 hours Route of administration: Transdermal

Locations

Country	Name	City	State
Germany	104	Alzenau
Germany	106	Aschaffenburg
Germany	105	Berlin
Germany	107	Böblingen
Germany	111	Düsseldorf
Germany	109	Erbach
Germany	110	Essen
Germany	102	Karlstadt
Germany	101	Köln
Germany	103	Stuttgart
Germany	108	Würzburg

Sponsors (3)

Lead Sponsor	Collaborator
UCB BIOSCIENCES GmbH	Bracket Global, Pharmaceutical Health Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5	No
Secondary	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 was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4	No
Secondary	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 was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5	No
Secondary	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 was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4	No
Secondary	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 was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5	No
Secondary	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 was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4	No
Secondary	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	Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5	No
Secondary	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.	Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5	No

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