<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/NCT02231905</url>
  </required_header>
  <id_info>
    <org_study_id>248.544</org_study_id>
    <nct_id>NCT02231905</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease</brief_title>
  <official_title>Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole</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 assess the safety, tolerability and effectiveness of a switching from Domin®&#xD;
      (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <primary_completion_date type="Actual">November 2004</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients who prematurely discontinued due to adverse event</measure>
    <time_frame>up to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the sum of UPDRS Part III (motor examination)</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Modified Hoehn &amp; Yahr scale</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Clinical global impression (CGI) of efficacy</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Blood Pressure, Pulse Rate</description>
  </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>Number of patients with clinically significant changes in electrocardiogram (ECG)</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>BI-Sifrol®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI-Sifrol®</intervention_name>
    <arm_group_label>BI-Sifrol®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with&#xD;
             talipexole (Domin®)&#xD;
&#xD;
          2. Patients who present stable symptoms and maintain the doses of talipexole and other&#xD;
             concomitant therapy for Parkinson's disease at least last 4 weeks&#xD;
&#xD;
          3. Male or female patients aged 20 and over&#xD;
&#xD;
          4. In or out-patients&#xD;
&#xD;
          5. Patient's severity characterized as Stage 1 - 5 by Modified Hoehn &amp; Yahr scale&#xD;
&#xD;
          6. Ability to provide written informed consent in accordance with the Good Clinical&#xD;
             Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant&#xD;
             laws such as the Pharmaceutical Affairs Law&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of hypersensitivity of pramipexole&#xD;
&#xD;
          2. Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium&#xD;
             and abnormal behavior&#xD;
&#xD;
          3. Subjective symptom derived from orthostatic hypotension&#xD;
&#xD;
          4. Hypotension (systolic blood pressure; 100 mmHg or less)&#xD;
&#xD;
          5. Complication such as clinically significant cardiac, renal and hepatic diseases&#xD;
&#xD;
          6. Patients who drive a car, operate a machine, work on heights or engage in other&#xD;
             hazardous activities&#xD;
&#xD;
          7. Pregnant, possibly pregnant or female in lactation&#xD;
&#xD;
          8. Patients who are participating in other drug studies or who receive other&#xD;
             investigational drugs within last 3 months before enrolled this study&#xD;
&#xD;
          9. Other than above, those who judged by the investigator or sub-investigator to be&#xD;
             inappropriate as for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</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 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 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/NCT02231905
org study id: 248.544
nct id: NCT02231905
lead sponsor: 
Study to assess the safety, tolerability and effectiveness of a switching from Domin®
      (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients who prematurely discontinued due to adverse event
time frame: up to 12 weeks
measure: Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
time frame: up to 12 weeks
measure: Change of the sum of UPDRS Part III (motor examination)
time frame: up to 12 weeks
measure: Change of Modified Hoehn & Yahr scale
time frame: up to 12 weeks
measure: Change of Clinical global impression (CGI) of efficacy
time frame: up to 12 weeks
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 12 weeks
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 12 weeks
description: Blood Pressure, Pulse Rate
measure: Number of patients with adverse events
time frame: up to 12 weeks
measure: Number of patients with clinically significant changes in electrocardiogram (ECG)
time frame: up to 12 weeks
arm group label: BI-Sifrol®
arm group type: Experimental
description: Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks.
intervention type: Drug
intervention name: BI-Sifrol®
arm group label: BI-Sifrol®
criteria: 
gender: All
minimum age: 20 Years
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