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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000932-41 | EudraCT Number |
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| Name | Class |
|---|---|
| Pharmaceutical Health Sciences | UNKNOWN |
| Bracket Global | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A-B | Experimental | 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) |
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| Treatment Arm B-A | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine (Test product PR 2.3.1) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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).
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 104 | Alzenau in Unterfranken | Germany | ||||
| 106 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29461870 | Derived | 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. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set.
This study started to enroll subjects in September 2014 in Germany and concluded in December 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm A-B | 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) |
| FG001 | Treatment Arm B-A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rotigotine (Reference product PR 2.1.1) | Drug |
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| 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 | 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).
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 |
| 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:
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 |
| 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:
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 |
| 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:
| 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:
| 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:
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 |
| Aschaffenburg |
| Germany |
| 105 | Berlin | Germany |
| 107 | Böblingen | Germany |
| 101 | Cologne | Germany |
| 111 | Düsseldorf | Germany |
| 109 | Erbach im Odenwald | Germany |
| 110 | Essen | Germany |
| 102 | Karlstadt am Main | Germany |
| 103 | Stuttgart | Germany |
| 108 | Würzburg | Germany |
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) |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm A-B | 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) |
| BG001 | Treatment Arm B-A | 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) |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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).
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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 |
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| 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).
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. | 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. | Posted | Number | percentage of patches | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | patches | Participants |
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| 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).
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. | 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. | Posted | Number | percentage of patches | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | patches | Participants |
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| 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:
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. | 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. | Posted | Number | percentage of patches | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | patches | Participants |
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| 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:
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. | 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. | Posted | Number | percentage of patches | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | patches | Participants |
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| 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:
| 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. | Posted | Number | percentage of patches | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | patches | Participants |
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| 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:
| 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. | Posted | Number | percentage of patches | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | patches | Participants |
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| 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:
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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 |
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Treatment-emergent Adverse Events were collected from Visit 2 (Day 1) up to the Safety Follow-up Visit (Day 12).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | 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). | 0 | 57 | 7 | 57 | ||
| EG001 | Treatment B | 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). | 0 | 57 | 1 | 57 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| >=65 years |
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| Male |
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| OG001 | Treatment B | Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 |
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| OG001 | Treatment B | Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 |
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| patches |
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| patches |
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| OG001 | Treatment B | 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). |
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