<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/NCT02248207</url>
  </required_header>
  <id_info>
    <org_study_id>248.527</org_study_id>
    <nct_id>NCT02248207</nct_id>
  </id_info>
  <brief_title>Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease</brief_title>
  <official_title>Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to obtain information about the co-operation of the different physician-colleagues in&#xD;
      the treatment of patients with Parkinson's disease, both in private practices and clinics and&#xD;
      about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to&#xD;
      collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's&#xD;
      disease under routing conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <primary_completion_date type="Actual">November 2003</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>Global Assessment of efficacy by investigator on a 4-point scale</measure>
    <time_frame>after 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in actual Parkinson symptoms</measure>
    <time_frame>Baseline, after 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>after 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1293</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson Disease patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole</intervention_name>
    <arm_group_label>Parkinson Disease patients</arm_group_label>
    <other_name>Sifrol®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Parkinson's disease recruited at specialist neurologist (private practices&#xD;
        and clinics)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Parkinson's disease who present to the specialist neurologist practice&#xD;
             for the first time without or with referral and who are planned to receive or either&#xD;
             be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can&#xD;
             be included in this observational study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologists are asked to consider the Summary of Product Characteristics (SPC) for&#xD;
             Sifrol®&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Pramipexole</mesh_term>
  </intervention_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/NCT02248207
org study id: 248.527
nct id: NCT02248207
lead sponsor: 
Study to obtain information about the co-operation of the different physician-colleagues in
      the treatment of patients with Parkinson's disease, both in private practices and clinics and
      about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to
      collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's
      disease under routing conditions
observational model: Cohort
time perspective: Prospective
measure: Global Assessment of efficacy by investigator on a 4-point scale
time frame: after 8 weeks
measure: Change from Baseline in actual Parkinson symptoms
time frame: Baseline, after 8 weeks
measure: Global Assessment of tolerability by investigator on a 4-point scale
time frame: after 8 weeks
measure: Number of patients with adverse drug reactions
time frame: up to 8 weeks
arm group label: Parkinson Disease patients
intervention type: Drug
intervention name: Pramipexole
arm group label: Parkinson Disease patients
other name: Sifrol®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Pramipexole