<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/NCT01673724</url>
  </required_header>
  <id_info>
    <org_study_id>SKL001</org_study_id>
    <nct_id>NCT01673724</nct_id>
  </id_info>
  <brief_title>Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease</brief_title>
  <official_title>Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sandoz</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sandoz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether pramipexole and bromocriptine are effective&#xD;
      in the treatment of non-motor symptoms in Parkinson's Disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between&#xD;
      Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment&#xD;
&#xD;
      SECONDARY OBJECTIVE&#xD;
&#xD;
        -  Evaluate the improvement for Depression which is one of the Nonmotor symptoms&#xD;
&#xD;
        -  Evaluate the improvement of clinical symptoms between two groups&#xD;
&#xD;
        -  Evaluate the improvement of Quality of Life between two groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 23, 2016</completion_date>
  <primary_completion_date type="Actual">May 23, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>K-NMSS</measure>
    <time_frame>24 weeks</time_frame>
    <description>Evaluate The total and each category score of K-NMSS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>K-MADRS</measure>
    <time_frame>24 weeks</time_frame>
    <description>Evaluate the Improvement of the depression refering to the total score of K-MADRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UPDRS I/II/III</measure>
    <time_frame>24 weeks</time_frame>
    <description>Evaluate the improvement of UPDRS I/II/III</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K-PDQ39</measure>
    <time_frame>24 weeks</time_frame>
    <description>Evaluate the improvement of Patient's QOL</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>pramipexole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bromocriptine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bromocriptine dosage form: white round tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pramipexole</intervention_name>
    <description>pramipexole</description>
    <arm_group_label>pramipexole</arm_group_label>
    <other_name>Sandoz Pramipexole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bromocriptine</intervention_name>
    <description>bromocriptine</description>
    <arm_group_label>Bromocriptine</arm_group_label>
    <other_name>Parlodel tab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease patients in accordance with UK Queensquare Brain Bank&#xD;
&#xD;
          -  modified Hoehn &amp; Yahr stage &lt;3&#xD;
&#xD;
          -  Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have&#xD;
             discontinued the agents at least four weeks before the screening in case of using the&#xD;
             dopamine agents are administered before.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  K-MMSE&lt;24&#xD;
&#xD;
          -  History of drug-induced Parkinsonism&#xD;
&#xD;
          -  secondary parkinsonism&#xD;
&#xD;
          -  History of schizophrenia or hallucination&#xD;
&#xD;
          -  Requirement of treatment with anti-depressants due to depressive disorder&#xD;
&#xD;
          -  Pregnant and/or breeding women&#xD;
&#xD;
          -  Renal inadequacy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seongbeom Koh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Youngnam University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangwon Nat'l University Hospital</name>
      <address>
        <city>Kangwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje university Sanggye Paik Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</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>
    <mesh_term>Bromocriptine</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/NCT01673724
org study id: SKL001
nct id: NCT01673724
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether pramipexole and bromocriptine are effective
      in the treatment of non-motor symptoms in Parkinson's Disease.
PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between
      Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

      SECONDARY OBJECTIVE

        -  Evaluate the improvement for Depression which is one of the Nonmotor symptoms

        -  Evaluate the improvement of clinical symptoms between two groups

        -  Evaluate the improvement of Quality of Life between two groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: K-NMSS
time frame: 24 weeks
description: Evaluate The total and each category score of K-NMSS
measure: K-MADRS
time frame: 24 weeks
description: Evaluate the Improvement of the depression refering to the total score of K-MADRS
measure: UPDRS I/II/III
time frame: 24 weeks
description: Evaluate the improvement of UPDRS I/II/III
measure: K-PDQ39
time frame: 24 weeks
description: Evaluate the improvement of Patient's QOL
arm group label: pramipexole
arm group type: Experimental
description: dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
arm group label: Bromocriptine
arm group type: Active Comparator
description: bromocriptine dosage form: white round tablet
intervention type: Drug
intervention name: pramipexole
description: pramipexole
arm group label: pramipexole
other name: Sandoz Pramipexole
intervention type: Drug
intervention name: Bromocriptine
description: bromocriptine
arm group label: Bromocriptine
other name: Parlodel tab
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Seongbeom Koh, MD
role: Principal Investigator
affiliation: Korea University Guro Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Pramipexole
mesh term: Bromocriptine