<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/NCT02265484</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-bromocriptine-01</org_study_id>
    <nct_id>NCT02265484</nct_id>
  </id_info>
  <brief_title>To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism</brief_title>
  <official_title>A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After successful screening of liver cirrhosis patients attending ILBS OPD for signs of&#xD;
      parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis&#xD;
      related parkinsonism will be made. Patients will be randomized into Bromocriptine and&#xD;
      Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS&#xD;
      (Institute of liver &amp; Biliary Sciences) for 3 months. Detailed neurological examination will&#xD;
      be done at each visit &amp; UPDRS (Unified Parkinson's Disease Rating Scale ) score will be&#xD;
      calculated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</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>The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cirrhosis Related Parkinsonism</condition>
  <arm_group>
    <arm_group_label>Lactulose + Rifaximin + Bromocriptine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactulose+Rifaximin+Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactulose+Rifaximin +Bromocriptine</intervention_name>
    <arm_group_label>Lactulose + Rifaximin + Bromocriptine</arm_group_label>
    <arm_group_label>Lactulose+Rifaximin+Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cirrhosis of liver with signs of parkinsonisms&#xD;
&#xD;
          -  Patients consented for the study protocol by signing the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years.&#xD;
&#xD;
          -  Patient s with HCC (Hepatocellular Carcinoma).&#xD;
&#xD;
          -  Patients diagnosed as Wilsons disease.&#xD;
&#xD;
          -  Patient who withdrew or non complaint to the study protocol.&#xD;
&#xD;
          -  ALF (Acute Liver failure)&#xD;
&#xD;
          -  Classical Parkinsonism&#xD;
&#xD;
          -  Atypical Parkinsonism&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hypotension&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  CAD&#xD;
&#xD;
          -  Psychiatric illness&#xD;
&#xD;
          -  Acute episode of Hepatic encephlopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amrish Sahney, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver &amp; Biliary Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2014</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</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>Liver Cirrhosis</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifaximin</mesh_term>
    <mesh_term>Bromocriptine</mesh_term>
    <mesh_term>Lactulose</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/NCT02265484
org study id: ILBS-bromocriptine-01
nct id: NCT02265484
lead sponsor: 
has dmc: No
After successful screening of liver cirrhosis patients attending ILBS OPD for signs of
      parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis
      related parkinsonism will be made. Patients will be randomized into Bromocriptine and
      Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS
      (Institute of liver & Biliary Sciences) for 3 months. Detailed neurological examination will
      be done at each visit & UPDRS (Unified Parkinson's Disease Rating Scale ) score will be
      calculated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
time frame: 3 months
measure: The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
time frame: 3 months
arm group label: Lactulose + Rifaximin + Bromocriptine
arm group type: Experimental
arm group label: Lactulose+Rifaximin+Placebo
arm group type: Active Comparator
intervention type: Drug
intervention name: Lactulose+Rifaximin +Bromocriptine
arm group label: Lactulose + Rifaximin + Bromocriptine
arm group label: Lactulose+Rifaximin+Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amrish Sahney, MD
role: Principal Investigator
affiliation: Institute of Liver & Biliary Sciences
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Parkinsonian Disorders
mesh term: Fibrosis
mesh term: Rifaximin
mesh term: Bromocriptine
mesh term: Lactulose