<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/NCT02248142</url>
  </required_header>
  <id_info>
    <org_study_id>248.623</org_study_id>
    <nct_id>NCT02248142</nct_id>
  </id_info>
  <brief_title>Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)</brief_title>
  <official_title>Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS</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 evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I&#xD;
      and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2006</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 RLS symptoms (IRLS) on a 4-point rating scale</measure>
    <time_frame>up to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of RLS severity on a 6-point rating scale</measure>
    <time_frame>up to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by investigator on a 5-point scale</measure>
    <time_frame>after 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maintenance dose of pramipexole</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1029</enrollment>
  <condition>Restless Legs Syndrome</condition>
  <arm_group>
    <arm_group_label>RLS patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole</intervention_name>
    <arm_group_label>RLS patients</arm_group_label>
    <other_name>Sifrol®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from moderate to severe RLS recruited at office-based neurologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from primary RLS who are planned to be initiated on treatment with&#xD;
             pramipexole as part of the routine care could be included into the study&#xD;
&#xD;
          -  Patients not pre-treated with any dopaminergic agent (de novo patients) or patients&#xD;
             pretreated with dopaminergic medication&#xD;
&#xD;
          -  Male or female patients of any age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treating physicians are asked to consider the regulations described in the Summary of&#xD;
             Product Characteristics (SPC) for the treatment with pramipexole&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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>Psychomotor Agitation</mesh_term>
    <mesh_term>Restless Legs Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02248142
org study id: 248.623
nct id: NCT02248142
lead sponsor: 
Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I
      and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)
observational model: Cohort
time perspective: Prospective
measure: Assessment of RLS symptoms (IRLS) on a 4-point rating scale
time frame: up to 12 weeks
measure: Assessment of RLS severity on a 6-point rating scale
time frame: up to 12 weeks
measure: Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale
time frame: up to 12 weeks
measure: Global assessment of efficacy by investigator on a 5-point scale
time frame: after 12 weeks
measure: Number of patients with adverse events
time frame: up to 12 weeks
measure: Time to reach maintenance dose of pramipexole
time frame: up to 12 weeks
arm group label: RLS patients
intervention type: Drug
intervention name: Pramipexole
arm group label: RLS patients
other name: Sifrol®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Psychomotor Agitation
mesh term: Restless Legs Syndrome
mesh term: Syndrome
mesh term: Pramipexole