<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/NCT02236728</url>
  </required_header>
  <id_info>
    <org_study_id>248.648</org_study_id>
    <nct_id>NCT02236728</nct_id>
  </id_info>
  <brief_title>Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole</brief_title>
  <official_title>Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)</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 primary objective of this study was to describe neurologists' population of patients&#xD;
      treated with pramipexole and suffering from Parkinson's disease (so called 'primary care'&#xD;
      population).&#xD;
&#xD;
      The secondary objectives were:&#xD;
&#xD;
        -  Evaluate the mean dose of pramipexole prescribed under actual conditions of use&#xD;
           depending on the severity of the disease.&#xD;
&#xD;
        -  Evaluate the reasons for choosing pramipexole as treatment.&#xD;
&#xD;
        -  Identify the patient profiles determining the choice of dose of pramipexole prescribed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <primary_completion_date type="Actual">November 2008</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 Patient's demographic characteristics</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Parkinson's disease characteristics</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Severity of the Parkinson Disease (PD)</measure>
    <time_frame>9 months</time_frame>
    <description>(levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the actual treatments of PD</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation for reasons for choosing pramipexole as treatment</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Treatment history</measure>
    <time_frame>9 months</time_frame>
    <description>3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">497</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's disease patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole</intervention_name>
    <arm_group_label>Parkinson's disease patients</arm_group_label>
    <other_name>(Sifrol®)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        neurologists' population of patients treated with pramipexole and suffering from&#xD;
        Parkinson's disease (so called 'primary care' population)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole&#xD;
             for at least two months, examined in consultation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusing to take part&#xD;
&#xD;
          -  Patient taking part in a clinical trial&#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 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 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/NCT02236728
org study id: 248.648
nct id: NCT02236728
lead sponsor: 
The primary objective of this study was to describe neurologists' population of patients
      treated with pramipexole and suffering from Parkinson's disease (so called 'primary care'
      population).

      The secondary objectives were:

        -  Evaluate the mean dose of pramipexole prescribed under actual conditions of use
           depending on the severity of the disease.

        -  Evaluate the reasons for choosing pramipexole as treatment.

        -  Identify the patient profiles determining the choice of dose of pramipexole prescribed
observational model: Cohort
time perspective: Prospective
measure: Assessment of Patient's demographic characteristics
time frame: 9 months
measure: Assessment of Parkinson's disease characteristics
time frame: 9 months
measure: Assessment of Severity of the Parkinson Disease (PD)
time frame: 9 months
description: (levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase)
measure: Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores
time frame: 9 months
measure: Description of the actual treatments of PD
time frame: 9 months
measure: Evaluation for reasons for choosing pramipexole as treatment
time frame: 9 months
measure: Assessment of Treatment history
time frame: 9 months
description: 3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment
measure: Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D
time frame: 9 months
measure: Number of patients with adverse events
time frame: 9 months
arm group label: Parkinson's disease patients
intervention type: Drug
intervention name: Pramipexole
arm group label: Parkinson's 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