Trial · NCT02230904
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
NCT02230904, Phase 1, Completed, UCB BIOSCIENCES GmbH; results first posted 2015-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease. Trials, record NCT02230904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02230904
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
- NCT number
- NCT02230904
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 57 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Parkinson's Disease
- Interventions
- Rotigotine (Test product PR 2.3.1), Rotigotine (Reference product PR 2.1.1)
- First posted
- 2014-09-03
- Last updated
- 2015-11-02
- Other registries' IDs
- eudract:2014-000932-41
- Results first posted
- 2015-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 | 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. |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | 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. |
| Secondary | Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | 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. |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | 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. |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | 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. |
| Secondary | Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | 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 |
| Secondary | Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | 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 |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 | 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. | units on a scale | MEAN |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | 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. | percentage of patches | NUMBER |
| SECONDARY | Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | 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. | percentage of patches | NUMBER |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | 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. | percentage of patches | NUMBER |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | 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. | percentage of patches | NUMBER |
| SECONDARY | Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4 | 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. | percentage of patches | NUMBER |
| SECONDARY | Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5 | 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. | percentage of patches | NUMBER |
| 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 | Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5 | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Treatment A | 1.04 | Standard Deviation 1.33 | units on a scale | |
| 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 | Treatment B | 2.15 | Standard Deviation 1.96 | units on a scale | |
| 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 | Treatment A | > 95 % | 65.4 | percentage of patches | |
| 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 | Treatment B | > 95 % | 46.2 | percentage of patches | |
| 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 | Treatment A | > 90 % - 95 % | 11.5 | percentage of patches | |
| 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 | Treatment B | > 90 % - 95 % | 17.3 | percentage of patches | |
| 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 | Treatment A | > 85 % - 90 % | 7.7 | percentage of patches | |
| 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 | Treatment B | > 85 % - 90 % | 5.8 | percentage of patches | |
| 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 | Treatment A | > 80 % - 85 % | 3.8 | percentage of patches | |
| 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 | Treatment B | > 80 % - 85 % | 9.6 | percentage of patches |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm A-B | 29 | |
| Overall Study | STARTED | Treatment Arm B-A | 28 | |
| Overall Study | COMPLETED | Treatment Arm A-B | 29 | |
| Overall Study | COMPLETED | Treatment Arm B-A | 27 | |
| Overall Study | NOT COMPLETED | Treatment Arm A-B | 0 | |
| Overall Study | NOT COMPLETED | Treatment Arm B-A | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Erythema | Skin and subcutaneous tissue disorders | Treatment A | 7 | 57 | 8 |
| other | Erythema | Skin and subcutaneous tissue disorders | Treatment B | 1 | 57 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A | ||
| Total, all-cause mortality | Treatment B | ||
| Total, other adverse events | Treatment A | 7 | 57 |
| Total, other adverse events | Treatment B | 1 | 57 |
| Total, serious adverse events | Treatment A | 0 | 57 |
| Total, serious adverse events | Treatment B | 0 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29461870 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment A vs Treatment B: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02230904
GET https://conductscience.org/api/trials/v1/NCT02230904/results?page=2