<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/NCT02248168</url>
  </required_header>
  <id_info>
    <org_study_id>248.599</org_study_id>
    <nct_id>NCT02248168</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease</brief_title>
  <official_title>Mirapex PMS Study Final Report</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as&#xD;
      shown below through the Post Marketing Surveillance (PMS) study upon approval.&#xD;
&#xD;
        -  Unexpected adverse events (especially, serious adverse events (SAEs))&#xD;
&#xD;
        -  To find out the status of incidence of adverse events under actual practice&#xD;
&#xD;
        -  Factors on the safety profile&#xD;
&#xD;
        -  Factors on the efficacy profile&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2002</start_date>
  <primary_completion_date type="Actual">January 2007</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>Assessment of Unified Parkinson's disease Rating Scale (UPDRS)</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Tremor at rest, Rigidity, Body bradykinesia and hypokinesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of efficacy by investigator on 3-point scale</measure>
    <time_frame>after 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1449</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>Pramipexole</intervention_name>
    <arm_group_label>Idiopathic Parkinson's disease patients</arm_group_label>
    <other_name>Mirapex®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with idiopathic Parkinson's disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX&#xD;
             Tablets first after a contract of the study to the requested number of cases will be&#xD;
             consecutively enrolled without skipping&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Following patients are contraindicated.&#xD;
&#xD;
               1. Patients who are hypersensitive to MIRAPEX or its ingredients&#xD;
&#xD;
               2. Refer to the insert paper for other contraindication.&#xD;
&#xD;
          -  Following patients should be carefully administered.&#xD;
&#xD;
               1. Patient with renal impairment&#xD;
&#xD;
               2. Refer to the insert paper for other precaution.&#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/NCT02248168
org study id: 248.599
nct id: NCT02248168
lead sponsor: 
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as
      shown below through the Post Marketing Surveillance (PMS) study upon approval.

        -  Unexpected adverse events (especially, serious adverse events (SAEs))

        -  To find out the status of incidence of adverse events under actual practice

        -  Factors on the safety profile

        -  Factors on the efficacy profile
observational model: Cohort
time perspective: Prospective
measure: Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
time frame: up to 4 weeks
description: Tremor at rest, Rigidity, Body bradykinesia and hypokinesia
measure: Number of patients with adverse events
time frame: up to 4 weeks
measure: Global Assessment of efficacy by investigator on 3-point scale
time frame: after 4 weeks
arm group label: Idiopathic Parkinson's disease patients
intervention type: Drug
intervention name: Pramipexole
arm group label: Idiopathic Parkinson's disease patients
other name: Mirapex®
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