<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/NCT02231255</url>
  </required_header>
  <id_info>
    <org_study_id>248.517</org_study_id>
    <nct_id>NCT02231255</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease</brief_title>
  <official_title>Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Documentation of the effect of an direct or overlapping switch from another dopamine agonist&#xD;
      to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the&#xD;
      reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the&#xD;
      switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic&#xD;
      Parkinson's disease under routine conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2002</start_date>
  <primary_completion_date type="Actual">December 2002</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>Reason for switch of therapy and reason for using Sifrol®</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Type of switch (abrupt or overlapping)</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in motor function by means of 5-points rating scale</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Short Parkinson's Evaluation Scale (SPES)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in psychopathological memory disturbances by means of 5- point rating scale</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Short Parkinson's Evaluation Scale (SPES)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in psychopathological thought disorder disturbances by means of 5- point rating scale</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>SPES score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in psychopathological depression disturbances by means of 5- point rating scale</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>SPES score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of mood on seven visual analogue scales (VASs)</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>assessed by patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Equivalent doses of Sifrol®</measure>
    <time_frame>after 8 weeks</time_frame>
    <description>compared to previous treatment dosing, based on global clinical impression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global assessment of efficacy by investigator on a 5-point rating 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>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 5-point rating scale</measure>
    <time_frame>after 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1216</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Idiopathic Parkinson's disease patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sifrol®</intervention_name>
    <arm_group_label>Idiopathic Parkinson's disease patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Idiopathic Parkinson's disease patients recruited at office-based neurologists,&#xD;
        psychiatrist or special neurology clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from&#xD;
             another dopamine agonist to Sifrol®&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologists and psychiatrists are asked to consider the Summary of Product&#xD;
             Characteristics (SPC) for 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 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 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/NCT02231255
org study id: 248.517
nct id: NCT02231255
lead sponsor: 
Documentation of the effect of an direct or overlapping switch from another dopamine agonist
      to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the
      reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the
      switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic
      Parkinson's disease under routine conditions
observational model: Cohort
time perspective: Prospective
measure: Reason for switch of therapy and reason for using Sifrol®
time frame: up to 8 weeks
description: questionnaire
measure: Type of switch (abrupt or overlapping)
time frame: up to 8 weeks
measure: Changes in motor function by means of 5-points rating scale
time frame: up to 8 weeks
description: Short Parkinson's Evaluation Scale (SPES)
measure: Changes in psychopathological memory disturbances by means of 5- point rating scale
time frame: up to 8 weeks
description: Short Parkinson's Evaluation Scale (SPES)
measure: Changes in psychopathological thought disorder disturbances by means of 5- point rating scale
time frame: up to 8 weeks
description: SPES score
measure: Changes in psychopathological depression disturbances by means of 5- point rating scale
time frame: up to 8 weeks
description: SPES score
measure: Changes of mood on seven visual analogue scales (VASs)
time frame: up to 8 weeks
description: assessed by patient
measure: Equivalent doses of Sifrol®
time frame: after 8 weeks
description: compared to previous treatment dosing, based on global clinical impression
measure: Global assessment of efficacy by investigator on a 5-point rating scale
time frame: after 8 weeks
measure: Number of patients with adverse drug reactions
time frame: up to 8 weeks
measure: Assessment of tolerability by investigator on a 5-point rating scale
time frame: after 8 weeks
arm group label: Idiopathic Parkinson's disease patients
intervention type: Drug
intervention name: Sifrol®
arm group label: Idiopathic Parkinson's disease patients
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