<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/NCT01711866</url>
  </required_header>
  <id_info>
    <org_study_id>PD0009</org_study_id>
    <nct_id>NCT01711866</nct_id>
  </id_info>
  <brief_title>A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease</brief_title>
  <official_title>An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4</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>
      The purpose of this study is to assess the safety and feasibility of switching subjects with&#xD;
      advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess&#xD;
      the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects&#xD;
      switched from previous treatment with either Pramipexole or Ropinirole.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 4</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 or Early Withdrawal Visit</measure>
    <time_frame>Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit</time_frame>
    <description>The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:&#xD;
0 = Side effects not assessable&#xD;
1 = No side effects&#xD;
2 = Side effects do not significantly interfere with subject's functioning&#xD;
3 = Side effects significantly interfere with the subject's functioning&#xD;
4 = Side effects outweigh therapeutic efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit</measure>
    <time_frame>Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit</time_frame>
    <description>The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:&#xD;
1 = Very much improved&#xD;
2 = Much improved&#xD;
3 = Minimally improved&#xD;
4 = No change&#xD;
5 = Minimally worse&#xD;
6 = Much worse&#xD;
7 = Very much worse.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Advanced Idiopathic Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Rotigotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.&#xD;
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.&#xD;
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rotigotine</intervention_name>
    <description>Rotigotine up to 16 mg / 24 hours, 4 weeks.</description>
    <arm_group_label>Rotigotine</arm_group_label>
    <other_name>Neupro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has idiopathic Parkinson's Disease of more than 3 years duration, as defined&#xD;
             by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following:&#xD;
             resting tremor, rigidity, impairment of postural reflexes and is without any other&#xD;
             known or suspected cause of Parkinsonism&#xD;
&#xD;
          -  Subject has motor fluctuations&#xD;
&#xD;
          -  Subject is not satisfactorily controlled following the investigator´s assessment on a&#xD;
             total daily dose of Pramipexole or Ropinirole&#xD;
&#xD;
          -  Subject has sleep disturbance or early morning motor impairment&#xD;
&#xD;
          -  Subject has experienced nocturia for at least 3 nights within 7 days prior to the&#xD;
             Baseline Visit&#xD;
&#xD;
          -  Subject is taking L-dopa in combination with Benserazide or Carbidopa and has been on&#xD;
             a stable dose of L-dopa for at least 28 days prior to the Baseline Visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has had 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, monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or&#xD;
             amphetamine&#xD;
&#xD;
          -  Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the&#xD;
             6 months prior to Baseline (Visit 2)&#xD;
&#xD;
          -  Subject has a history of significant skin hypersensitivity to adhesive or other&#xD;
             transdermal preparations, or recent unsolved contact dermatitis&#xD;
&#xD;
          -  Subject has a history of seizures or stroke within 1 year, or a history of myocardial&#xD;
             infarction within the last 6 months prior to enrollment&#xD;
&#xD;
          -  Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically&#xD;
             sterile or (ii) not using adequate birth control methods (including at least 1 barrier&#xD;
             method) or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal&#xD;
&#xD;
          -  Subject has 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>505</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>506</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>508</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>502</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>501</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>509</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>101</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>102</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>108</name>
      <address>
        <city>Daegu</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>105</name>
      <address>
        <city>Gyeonggi-Do</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>104</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>106</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>202</name>
      <address>
        <city>Sarawak</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>401</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>403</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301</name>
      <address>
        <city>Linkou</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>304</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>305</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Singapore</country>
    <country>Taiwan</country>
    <country>United States</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>February 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>February 25, 2014</results_first_submitted>
  <results_first_submitted_qc>February 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 7, 2014</results_first_posted>
  <last_update_submitted>February 25, 2014</last_update_submitted>
  <last_update_submitted_qc>February 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotigotine</keyword>
  <keyword>Neupro</keyword>
  <keyword>Switch</keyword>
  <keyword>Dopamine agonists</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 September 2012 in order to enroll 87 subjects in 5 countries.&#xD;
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.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Rotigotine</title>
          <description>First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.&#xD;
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.&#xD;
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.&#xD;
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
              </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="8"/>
              </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>Withdrawal by Subject</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="2"/>
              </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>First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.&#xD;
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.&#xD;
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.&#xD;
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
          </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="59.5" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </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="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </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 or Early Withdrawal Visit</title>
        <description>The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:&#xD;
0 = Side effects not assessable&#xD;
1 = No side effects&#xD;
2 = Side effects do not significantly interfere with subject's functioning&#xD;
3 = Side effects significantly interfere with the subject's functioning&#xD;
4 = Side effects outweigh therapeutic efficacy.</description>
        <time_frame>Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit</time_frame>
        <population>All 87 subjects of the Safety Set 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>First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.&#xD;
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.&#xD;
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.&#xD;
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit</title>
          <description>The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:&#xD;
0 = Side effects not assessable&#xD;
1 = No side effects&#xD;
2 = Side effects do not significantly interfere with subject's functioning&#xD;
3 = Side effects significantly interfere with the subject's functioning&#xD;
4 = Side effects outweigh therapeutic efficacy.</description>
          <population>All 87 subjects of the Safety Set 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="87"/>
              </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="58"/>
                  </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="26"/>
                  </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="0"/>
                  </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="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit</title>
        <description>The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:&#xD;
1 = Very much improved&#xD;
2 = Much improved&#xD;
3 = Minimally improved&#xD;
4 = No change&#xD;
5 = Minimally worse&#xD;
6 = Much worse&#xD;
7 = Very much worse.</description>
        <time_frame>Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit</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 35.</population>
        <group_list>
          <group group_id="O1">
            <title>Rotigotine</title>
            <description>First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.&#xD;
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.&#xD;
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.&#xD;
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit</title>
          <description>The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:&#xD;
1 = Very much improved&#xD;
2 = Much improved&#xD;
3 = Minimally improved&#xD;
4 = No change&#xD;
5 = Minimally worse&#xD;
6 = Much worse&#xD;
7 = Very much worse.</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 35.</population>
          <units>participants</units>
          <param>Number</param>
          <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>
              <title>PGIC category 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category ≥ 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGIC category ≥ 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </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 -1) to the Safety Follow-up Visit (up to Day 54).</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>First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.&#xD;
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.&#xD;
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.&#xD;
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.</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="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </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="30" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </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="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </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</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/NCT01711866
org study id: PD0009
nct id: NCT01711866
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the safety and feasibility of switching subjects with
      advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess
      the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects
      switched from previous treatment with either Pramipexole or Ropinirole.
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 or Early Withdrawal Visit
time frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
description: The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:
0 = Side effects not assessable
1 = No side effects
2 = Side effects do not significantly interfere with subject's functioning
3 = Side effects significantly interfere with the subject's functioning
4 = Side effects outweigh therapeutic efficacy.
measure: Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
time frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
description: The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:
1 = Very much improved
2 = Much improved
3 = Minimally improved
4 = No change
5 = Minimally worse
6 = Much worse
7 = Very much worse.
arm group label: Rotigotine
arm group type: Experimental
description: First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
intervention type: Drug
intervention name: Rotigotine
description: Rotigotine up to 16 mg / 24 hours, 4 weeks.
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: Korea, Republic of
country: Malaysia
country: Singapore
country: Taiwan
country: United States
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: 