<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/NCT02231294</url>
  </required_header>
  <id_info>
    <org_study_id>248.511</org_study_id>
    <nct_id>NCT02231294</nct_id>
  </id_info>
  <brief_title>The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease</brief_title>
  <official_title>The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.</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 SIFROL® on tremor and depression as well as its tolerability&#xD;
      in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2000</start_date>
  <primary_completion_date type="Actual">January 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>Change in Parkinson signs and symptoms by means of a 4-point rating scale</measure>
    <time_frame>up to 6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of tremor (rest and postural) by means of a 4-point rating scale</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Short Parkinson's Evaluation Scale (SPES)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in severity of kinetic tremor assessed by tremor spiral test</measure>
    <time_frame>up to 6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of depression by means of a 4-point SPES rating scale</measure>
    <time_frame>up to 6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in severity of depression by means of an 8-point rating scale</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Clinical Global Impression (CGI) rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>VAS (10 cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of efficacy by investigator on a 5-point rating scale</measure>
    <time_frame>after 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 5-point scale</measure>
    <time_frame>after 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by patient on a 5-point scale</measure>
    <time_frame>after 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1464</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>
        Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with idiopathic Parkinson's disease with tremor and/or depression requiring&#xD;
             therapy with Sifrol® or change of therapy to Sifro®l and not under medication with&#xD;
             neuroleptics were allowed to be observed during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who meet one or more of the general or specific contraindications mentioned&#xD;
             in the Summary of Product Characteristics (SPC) for Sifrol®&#xD;
&#xD;
          -  Patients under treatment with neuroleptics should not be observed during this study&#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 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 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/NCT02231294
org study id: 248.511
nct id: NCT02231294
lead sponsor: 
Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability
      in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions
observational model: Cohort
time perspective: Prospective
measure: Change in Parkinson signs and symptoms by means of a 4-point rating scale
time frame: up to 6 weeks
measure: Occurrence of tremor (rest and postural) by means of a 4-point rating scale
time frame: up to 6 weeks
description: Short Parkinson's Evaluation Scale (SPES)
measure: Change in severity of kinetic tremor assessed by tremor spiral test
time frame: up to 6 weeks
measure: Occurrence of depression by means of a 4-point SPES rating scale
time frame: up to 6 weeks
measure: Change in severity of depression by means of an 8-point rating scale
time frame: up to 6 weeks
description: Clinical Global Impression (CGI) rating scale
measure: Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)
time frame: up to 6 weeks
description: VAS (10 cm)
measure: Assessment of efficacy by investigator on a 5-point rating scale
time frame: after 6 weeks
measure: Number of patients with adverse drug reactions
time frame: up to 6 weeks
measure: Assessment of tolerability by investigator on a 5-point scale
time frame: after 6 weeks
measure: Assessment of tolerability by patient on a 5-point scale
time frame: after 6 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