<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230904</url>
  </required_header>
  <id_info>
    <org_study_id>PD0018</org_study_id>
    <secondary_id>2014-000932-41</secondary_id>
    <nct_id>NCT02230904</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB BIOSCIENCES GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pharmaceutical Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bracket Global</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to compare the adhesiveness of 2 different patch&#xD;
      formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that&#xD;
      both patch formulations show similar adhesiveness properties.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <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</measure>
    <time_frame>Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5</time_frame>
    <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).&#xD;
0 = &gt; 95 - 100 % of the patch area adheres&#xD;
1 = &gt; 90 - 95 % of the patch adheres&#xD;
2 = &gt; 85 - 90 % of the patch adheres&#xD;
3 = &gt; 80 - 85 % of the patch adheres&#xD;
4 = &gt; 75 - 80 % of the patch adheres&#xD;
5 = &gt; 70 - 75 % of the patch adheres&#xD;
6 = ≥ 50 - 70 % of the patch adheres&#xD;
7 = &lt; 50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.&#xD;
The average of patches 1 and 2 is presented by Treatment Arm below.</description>
  </primary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4</time_frame>
    <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).&#xD;
0 = &gt;95 - 100 % of the patch area adheres&#xD;
1 = &gt;90 - 95 % of the patch adheres&#xD;
2 = &gt;85 - 90 % of the patch adheres&#xD;
3 = &gt;80 - 85 % of the patch adheres&#xD;
4 = &gt;75 - 80 % of the patch adheres&#xD;
5 = &gt;70 - 75 % of the patch adheres&#xD;
6 = ≥50 - 70 % of the patch adheres&#xD;
7 = &lt;50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5</time_frame>
    <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).&#xD;
0 = &gt;95 - 100 % of the patch area adheres&#xD;
1 = &gt;90 - 95 % of the patch adheres&#xD;
2 = &gt;85 - 90 % of the patch adheres&#xD;
3 = &gt;80 - 85 % of the patch adheres&#xD;
4 = &gt;75 - 80 % of the patch adheres&#xD;
5 = &gt;70 - 75 % of the patch adheres&#xD;
6 = ≥50 - 70 % of the patch adheres&#xD;
7 = &lt;50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4</time_frame>
    <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5</time_frame>
    <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4</time_frame>
    <description>The subject assessed the patch adhesiveness by using the following score:&#xD;
0 = Satisfied with adhesiveness&#xD;
1 = Moderately satisfied with adhesiveness&#xD;
2 = Moderately unsatisfied with adhesiveness&#xD;
3 = Unsatisfied with adhesiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5</time_frame>
    <description>The subject assessed the patch adhesiveness by using the following score:&#xD;
0 = Satisfied with adhesiveness&#xD;
1 = Moderately satisfied with adhesiveness&#xD;
2 = Moderately unsatisfied with adhesiveness&#xD;
3 = Unsatisfied with adhesiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5</time_frame>
    <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Treatment Arm A-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm B-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rotigotine (Test product PR 2.3.1)</intervention_name>
    <description>Pharmaceutical form: Transdermal patch&#xD;
Concentration: 8 mg/24 hours&#xD;
Route of administration: Transdermal</description>
    <arm_group_label>Treatment Arm A-B</arm_group_label>
    <arm_group_label>Treatment Arm B-A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rotigotine (Reference product PR 2.1.1)</intervention_name>
    <description>Pharmaceutical form: Transdermal patch&#xD;
Concentration: 8 mg/24 hours&#xD;
Route of administration: Transdermal</description>
    <arm_group_label>Treatment Arm A-B</arm_group_label>
    <arm_group_label>Treatment Arm B-A</arm_group_label>
    <other_name>Neupro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a diagnosis of idiopathic Parkinson's Disease&#xD;
&#xD;
          -  Subject has been on continuous treatment with commercially available Rotigotine&#xD;
             transdermal patches (Neupro®) for at least 3 months prior to enrollment&#xD;
&#xD;
          -  Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2)&#xD;
             patch for at least 2 weeks prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has any medical or psychiatric condition which, in the opinion of the&#xD;
             investigator, could jeopardize or would compromise the subject's well-being or ability&#xD;
             to participate in this study&#xD;
&#xD;
          -  Subject has a history of significant skin hypersensitivity to adhesives or other&#xD;
             transdermal products or recently unsolved contact dermatitis&#xD;
&#xD;
          -  Subject has a history or present condition of an atopic or eczematous Dermatitis,&#xD;
             Psoriasis, or an active skin disease&#xD;
&#xD;
          -  Subject has a lifetime history of suicide attempt (including an active attempt,&#xD;
             interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6&#xD;
             months as indicated by a positive response ('yes') to either Question 4 or Question 5&#xD;
             of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or&#xD;
             Baseline (Visit 2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Clinical Trial Call Center</last_name>
    <role>Study Director</role>
    <affiliation>UCB Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>104</name>
      <address>
        <city>Alzenau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>106</name>
      <address>
        <city>Aschaffenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>105</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>107</name>
      <address>
        <city>Böblingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>111</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>109</name>
      <address>
        <city>Erbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>110</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>102</name>
      <address>
        <city>Karlstadt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>101</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>103</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>108</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>August 11, 2015</results_first_submitted>
  <results_first_submitted_qc>October 1, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 1, 2015</results_first_posted>
  <last_update_submitted>October 1, 2015</last_update_submitted>
  <last_update_submitted_qc>October 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotigotine patch</keyword>
  <keyword>Neupro</keyword>
  <keyword>Parkinson's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotigotine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study started to enroll subjects in September 2014 in Germany and concluded in December 2014.</recruitment_details>
      <pre_assignment_details>Participant Flow refers to the Randomized Set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment Arm A-B</title>
          <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)</description>
        </group>
        <group group_id="P2">
          <title>Treatment Arm B-A</title>
          <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)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Safety follow up could not take place</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>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.</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Arm A-B</title>
          <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)</description>
        </group>
        <group group_id="B2">
          <title>Treatment Arm B-A</title>
          <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)</description>
        </group>
        <group group_id="B3">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.3" spread="10.9"/>
                    <measurement group_id="B2" value="69.6" spread="9.5"/>
                    <measurement group_id="B3" value="68.4" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <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</title>
        <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).&#xD;
0 = &gt; 95 - 100 % of the patch area adheres&#xD;
1 = &gt; 90 - 95 % of the patch adheres&#xD;
2 = &gt; 85 - 90 % of the patch adheres&#xD;
3 = &gt; 80 - 85 % of the patch adheres&#xD;
4 = &gt; 75 - 80 % of the patch adheres&#xD;
5 = &gt; 70 - 75 % of the patch adheres&#xD;
6 = ≥ 50 - 70 % of the patch adheres&#xD;
7 = &lt; 50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.&#xD;
The average of patches 1 and 2 is presented by Treatment Arm below.</description>
        <time_frame>Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <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).</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <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).</description>
          </group>
        </group_list>
        <measure>
          <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</title>
          <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).&#xD;
0 = &gt; 95 - 100 % of the patch area adheres&#xD;
1 = &gt; 90 - 95 % of the patch adheres&#xD;
2 = &gt; 85 - 90 % of the patch adheres&#xD;
3 = &gt; 80 - 85 % of the patch adheres&#xD;
4 = &gt; 75 - 80 % of the patch adheres&#xD;
5 = &gt; 70 - 75 % of the patch adheres&#xD;
6 = ≥ 50 - 70 % of the patch adheres&#xD;
7 = &lt; 50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.&#xD;
The average of patches 1 and 2 is presented by Treatment Arm below.</description>
          <population>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.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="1.33"/>
                    <measurement group_id="O2" value="2.15" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.115</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.635</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <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</title>
        <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).&#xD;
0 = &gt;95 - 100 % of the patch area adheres&#xD;
1 = &gt;90 - 95 % of the patch adheres&#xD;
2 = &gt;85 - 90 % of the patch adheres&#xD;
3 = &gt;80 - 85 % of the patch adheres&#xD;
4 = &gt;75 - 80 % of the patch adheres&#xD;
5 = &gt;70 - 75 % of the patch adheres&#xD;
6 = ≥50 - 70 % of the patch adheres&#xD;
7 = &lt;50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1</description>
          </group>
        </group_list>
        <measure>
          <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</title>
          <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).&#xD;
0 = &gt;95 - 100 % of the patch area adheres&#xD;
1 = &gt;90 - 95 % of the patch adheres&#xD;
2 = &gt;85 - 90 % of the patch adheres&#xD;
3 = &gt;80 - 85 % of the patch adheres&#xD;
4 = &gt;75 - 80 % of the patch adheres&#xD;
5 = &gt;70 - 75 % of the patch adheres&#xD;
6 = ≥50 - 70 % of the patch adheres&#xD;
7 = &lt;50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.</description>
          <population>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.</population>
          <units>percentage of patches</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>patches</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 95 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4"/>
                    <measurement group_id="O2" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 90 % - 95 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 85 % - 90 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 80 % - 85 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 75 % - 80 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 70 % - 75 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;= 70 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2</title>
        <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).&#xD;
0 = &gt;95 - 100 % of the patch area adheres&#xD;
1 = &gt;90 - 95 % of the patch adheres&#xD;
2 = &gt;85 - 90 % of the patch adheres&#xD;
3 = &gt;80 - 85 % of the patch adheres&#xD;
4 = &gt;75 - 80 % of the patch adheres&#xD;
5 = &gt;70 - 75 % of the patch adheres&#xD;
6 = ≥50 - 70 % of the patch adheres&#xD;
7 = &lt;50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1</description>
          </group>
        </group_list>
        <measure>
          <title>Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2</title>
          <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).&#xD;
0 = &gt;95 - 100 % of the patch area adheres&#xD;
1 = &gt;90 - 95 % of the patch adheres&#xD;
2 = &gt;85 - 90 % of the patch adheres&#xD;
3 = &gt;80 - 85 % of the patch adheres&#xD;
4 = &gt;75 - 80 % of the patch adheres&#xD;
5 = &gt;70 - 75 % of the patch adheres&#xD;
6 = ≥50 - 70 % of the patch adheres&#xD;
7 = &lt;50 % of the patch adheres&#xD;
8 = Patch completely detached&#xD;
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group &quot;less than or equal to 70 % adhered or patch detachment&quot; which was regarded as significant patch adhesion failure in the draft EMA guideline.</description>
          <population>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.</population>
          <units>percentage of patches</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>patches</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 95 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.2"/>
                    <measurement group_id="O2" value="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 90 % - 95 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 85 % - 90 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 80 % - 85 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 75 % - 80 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 70 % - 75 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;= 70 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <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</title>
        <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1</description>
          </group>
        </group_list>
        <measure>
          <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</title>
          <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
          <population>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.</population>
          <units>percentage of patches</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>patches</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;= 90 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.9"/>
                    <measurement group_id="O2" value="63.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 % -&lt; 90 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                    <measurement group_id="O2" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 % -&lt; 75 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 50 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Detached</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <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</title>
        <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1</description>
          </group>
        </group_list>
        <measure>
          <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</title>
          <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
          <population>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.</population>
          <units>percentage of patches</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>patches</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;= 90 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.9"/>
                    <measurement group_id="O2" value="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 % -&lt; 90 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 % -&lt; 75 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 50 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Detached</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1</title>
        <description>The subject assessed the patch adhesiveness by using the following score:&#xD;
0 = Satisfied with adhesiveness&#xD;
1 = Moderately satisfied with adhesiveness&#xD;
2 = Moderately unsatisfied with adhesiveness&#xD;
3 = Unsatisfied with adhesiveness</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1</description>
          </group>
        </group_list>
        <measure>
          <title>Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1</title>
          <description>The subject assessed the patch adhesiveness by using the following score:&#xD;
0 = Satisfied with adhesiveness&#xD;
1 = Moderately satisfied with adhesiveness&#xD;
2 = Moderately unsatisfied with adhesiveness&#xD;
3 = Unsatisfied with adhesiveness</description>
          <population>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.</population>
          <units>percentage of patches</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>patches</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 = Satisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="65.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 = Moderately satisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 = Moderately unsatisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 = Unsatisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2</title>
        <description>The subject assessed the patch adhesiveness by using the following score:&#xD;
0 = Satisfied with adhesiveness&#xD;
1 = Moderately satisfied with adhesiveness&#xD;
2 = Moderately unsatisfied with adhesiveness&#xD;
3 = Unsatisfied with adhesiveness</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <description>Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1</description>
          </group>
        </group_list>
        <measure>
          <title>Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2</title>
          <description>The subject assessed the patch adhesiveness by using the following score:&#xD;
0 = Satisfied with adhesiveness&#xD;
1 = Moderately satisfied with adhesiveness&#xD;
2 = Moderately unsatisfied with adhesiveness&#xD;
3 = Unsatisfied with adhesiveness</description>
          <population>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.</population>
          <units>percentage of patches</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>patches</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 = Satisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.1"/>
                    <measurement group_id="O2" value="59.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 = Moderately satisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                    <measurement group_id="O2" value="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 = Moderately unsatisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 = Unsatisfied with adhesiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <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</title>
        <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
        <time_frame>Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment A</title>
            <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).</description>
          </group>
          <group group_id="O2">
            <title>Treatment B</title>
            <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).</description>
          </group>
        </group_list>
        <measure>
          <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</title>
          <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:&#xD;
0 (&gt;95-100% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
1 (&gt;90-95% of patch adheres) &gt;&gt; 0 (FDA/CDER)&#xD;
2 (&gt;85-90% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
3 (&gt;80-85% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
4 ( &gt;75-80% of patch adheres) &gt;&gt; 1 (FDA/CDER)&#xD;
5 (&gt;70-75% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
6 (≥50-70% of patch adheres) &gt;&gt; 2 (FDA/CDER)&#xD;
7 (&lt;50 % of patch adheres) &gt;&gt; 3 (FDA/CDER)&#xD;
8 (Patch completely detached) &gt;&gt; 4 (FDA/CDER)&#xD;
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.</description>
          <population>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.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.60"/>
                    <measurement group_id="O2" value="0.85" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.442</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.895</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent Adverse Events were collected from Visit 2 (Day 1) up to the Safety Follow-up Visit (Day 12).</time_frame>
      <desc>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.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment A</title>
          <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).</description>
        </group>
        <group group_id="E2">
          <title>Treatment B</title>
          <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).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>UCB (Study Director)</name_or_title>
      <organization>UCB Clinical Trial Call Center</organization>
      <phone>+1 887 822 9493</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230904
org study id: PD0018
secondary id: 2014-000932-41
nct id: NCT02230904
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
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
time frame: 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).
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.
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
time frame: 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).
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.
measure: Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
time frame: 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).
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.
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
time frame: 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:
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.
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
time frame: 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:
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.
measure: Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
time frame: 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:
0 = Satisfied with adhesiveness
1 = Moderately satisfied with adhesiveness
2 = Moderately unsatisfied with adhesiveness
3 = Unsatisfied with adhesiveness
measure: Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
time frame: 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:
0 = Satisfied with adhesiveness
1 = Moderately satisfied with adhesiveness
2 = Moderately unsatisfied with adhesiveness
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
time frame: 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:
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.
arm group label: Treatment Arm A-B
arm group type: Experimental
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)
arm group label: Treatment Arm B-A
arm group type: Experimental
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)
intervention type: Drug
intervention name: Rotigotine (Test product PR 2.3.1)
description: Pharmaceutical form: Transdermal patch
Concentration: 8 mg/24 hours
Route of administration: Transdermal
arm group label: Treatment Arm A-B
arm group label: Treatment Arm B-A
intervention type: Drug
intervention name: Rotigotine (Reference product PR 2.1.1)
description: Pharmaceutical form: Transdermal patch
Concentration: 8 mg/24 hours
Route of administration: Transdermal
arm group label: Treatment Arm A-B
arm group label: Treatment Arm B-A
other name: Neupro
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: UCB Pharma
facility: 
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country: Germany
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Rotigotine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 