<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/NCT01723904</url>
  </required_header>
  <id_info>
    <org_study_id>PD0015</org_study_id>
    <nct_id>NCT01723904</nct_id>
  </id_info>
  <brief_title>A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease</brief_title>
  <official_title>An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB BIOSCIENCES GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low&#xD;
      doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)&#xD;
      who have insufficient response to L-dopa and low doses dopamine receptor agonists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period</measure>
    <time_frame>Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable&#xD;
= No side effects&#xD;
= Side effects do not significantly interfere with subject's functioning&#xD;
= Side effects significantly interfere with the subject's functioning&#xD;
= Side effects outweigh therapeutic efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (&quot;on&quot; State) Total Score</measure>
    <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of &quot;on&quot; and &quot;Off&quot; State) Total Score</measure>
    <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).&#xD;
UPDRS Part II total score (average of &quot;on&quot; and &quot;off&quot; state) is the average of UPDRS Part II total score (&quot;on&quot; state) and Part II total score (&quot;off&quot; state).&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to the End of the Treatment Period in Absolute Time Spent &quot;Off&quot;</measure>
    <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>Absolute time spent &quot;off&quot; is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent &quot;off&quot; decreased from Baseline and therefore indicates an improvement from Baseline.&#xD;
Only subjects with time spent &quot;off&quot; at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to the End of the Treatment Period in Time Spent &quot;on&quot; Without Troublesome Dyskinesia</measure>
    <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>Absolute time spent &quot;on&quot; without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent &quot;on&quot; without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score</measure>
    <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score</measure>
    <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Advanced Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Rotigotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rotigotine</intervention_name>
    <description>Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
    <arm_group_label>Rotigotine</arm_group_label>
    <other_name>Neupro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is male or female, aged ≥ 30 and &lt; 80 years at informed consent&#xD;
&#xD;
          -  Subject has idiopathic Parkinson's Disease, of more than 3 years duration, as defined&#xD;
             by the cardinal sign, bradykinesia, and the presence of at least 1 of the following:&#xD;
             resting tremor, rigidity, impairment of postural reflexes, and without any known or&#xD;
             suspected cause of Parkinsonism&#xD;
&#xD;
          -  Subject has motor fluctuations such as wearing, dyskinesia&#xD;
&#xD;
          -  Subject has experienced nocturias for at least 3 nights within 7 days prior to&#xD;
             Baseline&#xD;
&#xD;
          -  Subject is taking levodopa (L-DOPA, immediate and/or controlled release) in&#xD;
             combination with benserazide or carbidopa and has been on a stable dose of L-DOPA for&#xD;
             at least 28 days prior to Baseline (Visit 2)&#xD;
&#xD;
          -  Subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole&#xD;
             ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least&#xD;
             28 days prior to Baseline (Visit 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is receiving therapy with tolcapone or budipine&#xD;
&#xD;
          -  Subject is receiving therapy with one of the following drugs either concurrently or&#xD;
             within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide,&#xD;
             reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine,&#xD;
             ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A)&#xD;
             inhibitors, methylphenidate, or amphetamine&#xD;
&#xD;
          -  Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within&#xD;
             the 6 months prior to Baseline (Visit 2)&#xD;
&#xD;
          -  Subject has a known hypersensitivity to any components of the study medication, such&#xD;
             as a history of significant skin hypersensitivity to adhesives, known hypersensitivity&#xD;
             to other transdermal medications, or has unresolved contact dermatitis&#xD;
&#xD;
          -  Subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not&#xD;
             surgically sterile, or, (ii) not using adequate birth control methods [including at&#xD;
             least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2&#xD;
             years post menopausal)&#xD;
&#xD;
          -  Subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs&#xD;
             syndrome, or periodic limb movement disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Clinical Trial Call Center</last_name>
    <role>Study Director</role>
    <affiliation>+1 877 822 9493 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>402</name>
      <address>
        <city>Chatswood</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>401</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>403</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>104</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>112</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>109</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>111</name>
      <address>
        <city>Gyeonggi-Do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>101</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>102</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>103</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>105</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>107</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>108</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>110</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>202</name>
      <address>
        <city>Kuala Terengganu</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>204</name>
      <address>
        <city>Kuching Sarawak</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>201</name>
      <address>
        <city>Pulau Pinang</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>501</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>502</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>302</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>303</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>306</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Singapore</country>
    <country>Taiwan</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>May 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <results_first_submitted>March 11, 2014</results_first_submitted>
  <results_first_submitted_qc>May 7, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 3, 2014</results_first_posted>
  <last_update_submitted>May 7, 2014</last_update_submitted>
  <last_update_submitted_qc>May 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotigotine</keyword>
  <keyword>Neupro</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 multicenter study started to enroll subjects in 5 countries in October 2012.</recruitment_details>
      <pre_assignment_details>Participant Flow refers to the Safety Set (SS). SS consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rotigotine</title>
          <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Noncompliant</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to follow protocol/ judged by inv</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics refer to the Safety Set. The Safety Set consists of all subjects who had at least one patch application.</population>
      <group_list>
        <group group_id="B1">
          <title>Rotigotine</title>
          <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="61.3" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </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="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period</title>
        <description>The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable&#xD;
= No side effects&#xD;
= Side effects do not significantly interfere with subject's functioning&#xD;
= Side effects significantly interfere with the subject's functioning&#xD;
= Side effects outweigh therapeutic efficacy.</description>
        <time_frame>Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period</title>
          <description>The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable&#xD;
= No side effects&#xD;
= Side effects do not significantly interfere with subject's functioning&#xD;
= Side effects significantly interfere with the subject's functioning&#xD;
= Side effects outweigh therapeutic efficacy.</description>
          <population>From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGI Item 4 score of 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGI Item 4 score of 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGI Item 4 score of 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGI Item 4 score of 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGI Item 4 score of 3 or 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (&quot;on&quot; State) Total Score</title>
        <description>The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.</description>
        <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (&quot;on&quot; State) Total Score</title>
          <description>The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.</description>
          <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</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="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of &quot;on&quot; and &quot;Off&quot; State) Total Score</title>
        <description>UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).&#xD;
UPDRS Part II total score (average of &quot;on&quot; and &quot;off&quot; state) is the average of UPDRS Part II total score (&quot;on&quot; state) and Part II total score (&quot;off&quot; state).&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.</description>
        <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of &quot;on&quot; and &quot;Off&quot; State) Total Score</title>
          <description>UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).&#xD;
UPDRS Part II total score (average of &quot;on&quot; and &quot;off&quot; state) is the average of UPDRS Part II total score (&quot;on&quot; state) and Part II total score (&quot;off&quot; state).&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.</description>
          <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</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="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to the End of the Treatment Period in Absolute Time Spent &quot;Off&quot;</title>
        <description>Absolute time spent &quot;off&quot; is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent &quot;off&quot; decreased from Baseline and therefore indicates an improvement from Baseline.&#xD;
Only subjects with time spent &quot;off&quot; at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.</description>
        <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>Subjects with time spent &quot;off&quot; at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the End of the Treatment Period in Absolute Time Spent &quot;Off&quot;</title>
          <description>Absolute time spent &quot;off&quot; is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent &quot;off&quot; decreased from Baseline and therefore indicates an improvement from Baseline.&#xD;
Only subjects with time spent &quot;off&quot; at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.</description>
          <population>Subjects with time spent &quot;off&quot; at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
          <units>hours/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to the End of the Treatment Period in Time Spent &quot;on&quot; Without Troublesome Dyskinesia</title>
        <description>Absolute time spent &quot;on&quot; without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent &quot;on&quot; without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline.</description>
        <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the End of the Treatment Period in Time Spent &quot;on&quot; Without Troublesome Dyskinesia</title>
          <description>Absolute time spent &quot;on&quot; without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent &quot;on&quot; without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline.</description>
          <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
          <units>hours/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score</title>
        <description>The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.</description>
        <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score</title>
          <description>The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.</description>
          <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</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="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score</title>
        <description>The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.</description>
        <time_frame>From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)</time_frame>
        <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.&#xD;
A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.</description>
          <population>Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.</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="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -7) to the Safety Follow-up Visit (up to Day 78).</time_frame>
      <desc>Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rotigotine</title>
          <description>- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.&#xD;
Duration of the Titration Period: Between 1 week and 5 weeks.&#xD;
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.&#xD;
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.&#xD;
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngeal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</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="35" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="90"/>
              </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 Clinical Trial Call Center</name_or_title>
      <organization>UCB</organization>
      <phone>+1 877 822 9493 (UCB)</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/NCT01723904
org study id: PD0015
nct id: NCT01723904
lead sponsor: 
collaborator: 
has dmc: No
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low
      doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)
      who have insufficient response to L-dopa and low doses dopamine receptor agonists.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period
time frame: Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable
= No side effects
= Side effects do not significantly interfere with subject's functioning
= Side effects significantly interfere with the subject's functioning
= Side effects outweigh therapeutic efficacy.
measure: Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III ("on" State) Total Score
time frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.
A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.
measure: Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of "on" and "Off" State) Total Score
time frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).
UPDRS Part II total score (average of "on" and "off" state) is the average of UPDRS Part II total score ("on" state) and Part II total score ("off" state).
A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.
measure: Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off"
time frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: Absolute time spent "off" is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent "off" decreased from Baseline and therefore indicates an improvement from Baseline.
Only subjects with time spent "off" at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.
measure: Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia
time frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: Absolute time spent "on" without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent "on" without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline.
measure: Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score
time frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.
A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.
measure: Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score
time frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
description: The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.
A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.
arm group label: Rotigotine
arm group type: Experimental
description: - Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
intervention type: Drug
intervention name: Rotigotine
description: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.
arm group label: Rotigotine
other name: Neupro
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: +1 877 822 9493 (UCB)
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country: Australia
country: Korea, Republic of
country: Malaysia
country: Singapore
country: Taiwan
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: 