<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/NCT01683253</url>
  </required_header>
  <id_info>
    <org_study_id>SKL004</org_study_id>
    <nct_id>NCT01683253</nct_id>
  </id_info>
  <brief_title>Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa</brief_title>
  <acronym>REIN-PD</acronym>
  <official_title>The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved&#xD;
      and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist&#xD;
      to levodopa/carbidopa in patients with Parkinson's disease who have been treated with&#xD;
      dopaminergic medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota&#xD;
           Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or&#xD;
           LOCF(Last Observation Carried Forward)&#xD;
&#xD;
        -  SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the&#xD;
           baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified&#xD;
           Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mMIDI(modified Minnesota Impulsive Disorders Interview)</measure>
    <time_frame>12weeks</time_frame>
    <description>To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric profile</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF&#xD;
* Neuropsychological assessment&#xD;
General cognitive status: K-Minimental status exam(K-MMSE)&#xD;
Psychiatric profile:&#xD;
Neuropsychiatric inventory (K-NPI)&#xD;
Beck depression inventory (BDI)&#xD;
Barratt impulsiveness scale (BIS)&#xD;
Beck anxiety inventory (BAI)&#xD;
State-trait anger expression inventory (STAXI)&#xD;
Obsessive compulsive inventory (OCI)&#xD;
Evaluation of global change:&#xD;
Patient global impression of improvement (PGI-I)&#xD;
Clinical global impression of improvement (CGI-I)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Impulse Control Disorder</condition>
  <arm_group>
    <arm_group_label>Levodopa/Carbidopa(200mg/50mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control A (dopaminergic agonist )</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parkinson patients treated with anti-Parkinson drug over 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control B (no drug)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parkinson diseased patients not treated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levodopa/Carbidopa(200mg/50mg)</intervention_name>
    <arm_group_label>Levodopa/Carbidopa(200mg/50mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dopaminergic Agonists</intervention_name>
    <description>Treated for at least 6 months after diagnosis of Parkinson's Disease.</description>
    <arm_group_label>Control A (dopaminergic agonist )</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's&#xD;
             Disease Brain Bank Criteria&#xD;
&#xD;
          -  mMIDI ≥ 3 score with ICD&#xD;
&#xD;
          -  Patients must be on an anti-parkinson treatment at least 6 months before screening.&#xD;
&#xD;
          -  for this protocol, dopamine agonists should be included in his/her anti-parkinson&#xD;
             treatment.&#xD;
&#xD;
          -  30years ≤ patients &lt; 80years of age, male or female&#xD;
&#xD;
          -  patients must give written informed consent before any assessment is performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement of treatment with serious cognitive disorder, behavioral disorder, or&#xD;
             mental illness currently or in the future&#xD;
&#xD;
          -  for the patients ≤ 65years: K-MMSE(korean version of Mini-Mental State Exam) ≤24, or&#xD;
             for the patients ≥ 66years: K-MMSE ≤ 20, or the patients have dementia(incl. early&#xD;
             dementia) even though K-MMSE score is more than 20&#xD;
&#xD;
          -  Requirement of treatment more than 6times per day due to the severe motor fluctuation.&#xD;
&#xD;
          -  Severe dyskinesia&#xD;
&#xD;
          -  DBS(Deep Brain Stimulation)or any other surgical treatment&#xD;
&#xD;
          -  History of melanoma or not-diagnostic skin trouble/skin lesions&#xD;
&#xD;
          -  narrow angle glaucoma&#xD;
&#xD;
          -  clinically serious surgical or medical condition&#xD;
&#xD;
          -  malignant tumor&#xD;
&#xD;
          -  use of other investigational drugs at the time of enrollment within 4weeks&#xD;
&#xD;
          -  pregnant, nursing or lactating women&#xD;
&#xD;
          -  women of child-bearing potential&#xD;
&#xD;
          -  history of hypersensitivity or allergy to levodopa/carbidopa&#xD;
&#xD;
          -  any serious disease according to the investigator's discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinwhan Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sandoz Investigative Site</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandoz Investigative Site</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandoz Investigative Site</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandoz Investigative Site</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandoz Investigative Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</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>Disruptive, Impulse Control, and Conduct Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Levodopa</mesh_term>
    <mesh_term>Carbidopa</mesh_term>
    <mesh_term>Dopamine Agonists</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/NCT01683253
org study id: SKL004
nct id: NCT01683253
lead sponsor: 
has dmc: No
is fda regulated drug: No
The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved
      and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist
      to levodopa/carbidopa in patients with Parkinson's disease who have been treated with
      dopaminergic medications.
-  PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota
           Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or
           LOCF(Last Observation Carried Forward)

        -  SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the
           baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified
           Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mMIDI(modified Minnesota Impulsive Disorders Interview)
time frame: 12weeks
description: To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
measure: Neuropsychiatric profile
time frame: 12 weeks
description: To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF
* Neuropsychological assessment
General cognitive status: K-Minimental status exam(K-MMSE)
Psychiatric profile:
Neuropsychiatric inventory (K-NPI)
Beck depression inventory (BDI)
Barratt impulsiveness scale (BIS)
Beck anxiety inventory (BAI)
State-trait anger expression inventory (STAXI)
Obsessive compulsive inventory (OCI)
Evaluation of global change:
Patient global impression of improvement (PGI-I)
Clinical global impression of improvement (CGI-I)
arm group label: Levodopa/Carbidopa(200mg/50mg)
arm group type: Experimental
arm group label: Control A (dopaminergic agonist )
arm group type: Experimental
description: Parkinson patients treated with anti-Parkinson drug over 6 months.
arm group label: Control B (no drug)
arm group type: No Intervention
description: Parkinson diseased patients not treated.
intervention type: Drug
intervention name: Levodopa/Carbidopa(200mg/50mg)
arm group label: Levodopa/Carbidopa(200mg/50mg)
intervention type: Drug
intervention name: Dopaminergic Agonists
description: Treated for at least 6 months after diagnosis of Parkinson's Disease.
arm group label: Control A (dopaminergic agonist )
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jinwhan Cho, MD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Disruptive, Impulse Control, and Conduct Disorders
mesh term: Dopamine
mesh term: Levodopa
mesh term: Carbidopa
mesh term: Dopamine Agonists