<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/NCT02227355</url>
  </required_header>
  <id_info>
    <org_study_id>PD0013</org_study_id>
    <nct_id>NCT02227355</nct_id>
  </id_info>
  <brief_title>Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease</brief_title>
  <acronym>NEUPART</acronym>
  <official_title>A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Biopharma S.P.R.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PRA Health Sciences</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 aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy&#xD;
      for younger and older patients with Parkinson's Disease under real life conditions. Effects&#xD;
      on ability to perform activities of daily living, sleep, medication dose and other factors&#xD;
      will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score</measure>
    <time_frame>Baseline to end of Observational Period (6 months)</time_frame>
    <description>The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to end of the Observational Period in L-dopa dose</measure>
    <time_frame>Baseline to end of Observational Period (6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score</measure>
    <time_frame>Baseline to end of Observational Period (6 months)</time_frame>
    <description>The PDSS-2 is a 15 item scale that is used to assess sleep and nocturnal disability in Parkinson's Disease. It is designed for interviewer-administered completion or self-completion by patients.&#xD;
Patients are asked to rate how often during the past week he/she slept well or experienced various symptoms of sleep disability. Each of the 15 items are to be scored between 0 (never) to 4 (very often) with the total score ranging from 0 to 60; the higher the sum score, the greater the degree of impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score</measure>
    <time_frame>End of the Observation Period (Month 6)</time_frame>
    <description>The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions = 52 points maximum); the higher the sum score, the greater degree of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition)</measure>
    <time_frame>End of the Observation Period (Month 6)</time_frame>
    <description>CGI Item 2 (Global Rating of Change of Condition) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. Scores range from 0 to 7 as follows: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">195</enrollment>
  <condition>Idiopathic Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>PD Patients &lt; 70 years of age</arm_group_label>
    <description>Patients with Parkinson's Disease (PD) &lt;70 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PD Patients ≥ 70 years of age</arm_group_label>
    <description>Patients with Parkinson's Disease (PD) ≥ 70 years of age.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with idiopathic Parkinson's Disease receiving levodopa as monotherapy or in&#xD;
        combination with a dopamine agonist other than Rotigotine, but either not sufficiently&#xD;
        controlled on or intolerant to current treatment, or other reason; patients are receiving&#xD;
        treatment in general practitioner (GP) offices, private clinics or hospitals (including&#xD;
        university hospitals) according to routine daily practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The following selection criteria must be followed for patients entering the&#xD;
        Noninterventional Study (NIS):&#xD;
&#xD;
          -  The decision by the treating physician to prescribe Rotigotine transdermal patch is&#xD;
             made before participating in the NIS due to a clinical therapeutic indication (e.g.,&#xD;
             because of intolerance and/or ineffectiveness of another dopamine agonist)&#xD;
&#xD;
          -  The patient is either male or female and over 18 years of age&#xD;
&#xD;
          -  A Patient Data Consent form is signed and dated by the patient or by the legal&#xD;
             representative&#xD;
&#xD;
          -  The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28&#xD;
             days prior to the Baseline Visit and is willing to participate in questionnaire based&#xD;
             assessments&#xD;
&#xD;
          -  The patient is receiving L-dopa as monotherapy or a combination therapy composed of&#xD;
             L-dopa and a dopamine agonist other than Rotigotine&#xD;
&#xD;
          -  The patient has been on L-dopa therapy for at least 6 months and is responding to&#xD;
             initial L-dopa therapy&#xD;
&#xD;
          -  The patient has a Hoehn and Yahr stage score of 1 to 4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from the study if they have participated in a clinical study&#xD;
             of a medication or a medical device within 3 months prior to Baseline or if they are&#xD;
             participating in a clinical study at the time of inclusion or have already&#xD;
             participated in the current study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Clinical Trial Call Center</last_name>
    <role>Study Director</role>
    <affiliation>+1 877 822 9493 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>42</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>41</name>
      <address>
        <city>Mougins</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>40</name>
      <address>
        <city>Nimes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>6</name>
      <address>
        <city>Alzenau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>51</name>
      <address>
        <city>Aschaffenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>13</name>
      <address>
        <city>Beelitz-Heilstätten</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>12</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>5</name>
      <address>
        <city>Böblingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>53</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>7</name>
      <address>
        <city>Erbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>4</name>
      <address>
        <city>Haag</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>11</name>
      <address>
        <city>Leer</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>54</name>
      <address>
        <city>Schriesheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>8</name>
      <address>
        <city>Senftenberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>14</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>10</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>3</name>
      <address>
        <city>Westerstede</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>45</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>47</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>60</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>29</name>
      <address>
        <city>Cosenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>30</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>46</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>27</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>28</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>62</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>20</name>
      <address>
        <city>Barakaldo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>15</name>
      <address>
        <city>Donostia San Sebastian</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>24</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>22</name>
      <address>
        <city>Palma de Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>37</name>
      <address>
        <city>Bury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>49</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>52</name>
      <address>
        <city>Lincoln</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>48</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>33</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>36</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>34</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>31</name>
      <address>
        <city>Middlesborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>38</name>
      <address>
        <city>North Shields</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>35</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>63</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>July 1, 2016</last_update_submitted>
  <last_update_submitted_qc>July 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Neupro®</keyword>
  <keyword>Rotigotine</keyword>
  <keyword>Transdermal patch</keyword>
  <keyword>NEUPART</keyword>
  <keyword>Levodopa</keyword>
  <keyword>Noninterventional</keyword>
  <keyword>Combination therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02227355
org study id: PD0013
nct id: NCT02227355
lead sponsor: 
collaborator: 
has dmc: No
This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy
      for younger and older patients with Parkinson's Disease under real life conditions. Effects
      on ability to perform activities of daily living, sleep, medication dose and other factors
      will be assessed.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
time frame: Baseline to end of Observational Period (6 months)
description: The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability).
measure: Change from Baseline to end of the Observational Period in L-dopa dose
time frame: Baseline to end of Observational Period (6 months)
measure: Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score
time frame: Baseline to end of Observational Period (6 months)
description: The PDSS-2 is a 15 item scale that is used to assess sleep and nocturnal disability in Parkinson's Disease. It is designed for interviewer-administered completion or self-completion by patients.
Patients are asked to rate how often during the past week he/she slept well or experienced various symptoms of sleep disability. Each of the 15 items are to be scored between 0 (never) to 4 (very often) with the total score ranging from 0 to 60; the higher the sum score, the greater the degree of impairment.
measure: Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
time frame: End of the Observation Period (Month 6)
description: The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions = 52 points maximum); the higher the sum score, the greater degree of disability.
measure: Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition)
time frame: End of the Observation Period (Month 6)
description: CGI Item 2 (Global Rating of Change of Condition) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. Scores range from 0 to 7 as follows: 0=not assessed, 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: PD Patients < 70 years of age
description: Patients with Parkinson's Disease (PD) <70 years of age.
arm group label: PD Patients ≥ 70 years of age
description: Patients with Parkinson's Disease (PD) ≥ 70 years of age.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: +1 877 822 9493 (UCB)
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country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Parkinson Disease