<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/NCT01684475</url>
  </required_header>
  <id_info>
    <org_study_id>CJH1 Trial</org_study_id>
    <nct_id>NCT01684475</nct_id>
  </id_info>
  <brief_title>A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASE</brief_title>
  <official_title>A STUDY TO EVALUATE THE EFFICACY OF CJH1 [CLR4001] IN THE TREATMENT OF PARKINSON'S DISEASE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandra Marine and General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandra Marine and General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of&#xD;
      dopamine receptors and thereby reduce symptoms of Parkinson's Disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date>September 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduced signs and symptoms of Parkinson's disease</measure>
    <time_frame>8 weeks</time_frame>
    <description>Reduced signs and symptoms of Parkinson's disease</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Treatment with CJH1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJH1 (CLR4001)</intervention_name>
    <arm_group_label>Treatment with CJH1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient's with Parkinson's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to study medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gateway Rural Health Research</name>
      <address>
        <city>Goderich</city>
        <state>Ontario</state>
        <zip>N7A 1W5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Craig Hudson, MD</last_name>
      <phone>519-524-8323</phone>
    </contact>
    <investigator>
      <last_name>Craig J Hudson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandra Marine and General Hospital</investigator_affiliation>
    <investigator_full_name>Craig Hudson MD</investigator_full_name>
    <investigator_title>Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>Novel Treatment Parkinson's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_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/NCT01684475
org study id: CJH1 Trial
nct id: NCT01684475
lead sponsor: 
has dmc: No
The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of
      dopamine receptors and thereby reduce symptoms of Parkinson's Disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduced signs and symptoms of Parkinson's disease
time frame: 8 weeks
description: Reduced signs and symptoms of Parkinson's disease
arm group label: Treatment with CJH1
arm group type: Experimental
intervention type: Drug
intervention name: CJH1 (CLR4001)
arm group label: Treatment with CJH1
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Alexandra Marine and General Hospital
investigator full name: Craig Hudson MD
investigator title: Psychiatrist
mesh term: Parkinson Disease