<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/NCT03296176</url>
  </required_header>
  <id_info>
    <org_study_id>49RC17_0086</org_study_id>
    <nct_id>NCT03296176</nct_id>
  </id_info>
  <brief_title>Metabolomic Study in Huntington's Disease (METABO-HD)</brief_title>
  <official_title>Metabolomic Study in Huntington's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to study Huntington's disease by metabolomic approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>metabolite mass</measure>
    <time_frame>at baseline</time_frame>
    <description>by chromatography and mass spectrometry</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>presymptomatic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>symptomatic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <description>blood sample for metabolome analyse</description>
    <arm_group_label>controls</arm_group_label>
    <arm_group_label>presymptomatic</arm_group_label>
    <arm_group_label>symptomatic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For all groups:&#xD;
&#xD;
          -  age between 20 and 70 years&#xD;
&#xD;
          -  signature of the informed consent&#xD;
&#xD;
          -  covered by social security&#xD;
&#xD;
        For presymptomatic group:&#xD;
&#xD;
          -  positive genetic test with CAG repeat length ≥ 37 in HTT gene&#xD;
&#xD;
          -  Unified Huntington Disease Rating Scale ≤ 5&#xD;
&#xD;
        For symptomatic group:&#xD;
&#xD;
          -  positive genetic test with CAG repeat length ≥ 37 in HTT gene&#xD;
&#xD;
          -  The Unified Huntington's Disease Rating Scale motor score ≥ 6&#xD;
&#xD;
          -  The Total Functional Capacity score ≥ 11&#xD;
&#xD;
        Exclusion Criteria for all groups:&#xD;
&#xD;
          -  participation in another therapeutic trial (3 months exclusion period)&#xD;
&#xD;
          -  pregnancy and breastfeeding&#xD;
&#xD;
          -  persons deprived of their liberty by judicial or administrative decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe Verny, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christophe Verny, PU-PH</last_name>
    <phone>0241355615</phone>
    <email>Chverny@chu-angers.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dominique Bonneau, PU-PH</last_name>
    <phone>0241355615</phone>
    <email>dobonneau@chu-angers.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>VERNY</last_name>
      <phone>02.41.35.78.56</phone>
      <phone_ext>33</phone_ext>
      <email>chverny@chu-angers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 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>Huntington 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/NCT03296176
org study id: 49RC17_0086
nct id: NCT03296176
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to study Huntington's disease by metabolomic approach.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: metabolite mass
time frame: at baseline
description: by chromatography and mass spectrometry
arm group label: presymptomatic
arm group type: Experimental
arm group label: symptomatic
arm group type: Experimental
arm group label: controls
arm group type: Other
intervention type: Biological
intervention name: blood sample
description: blood sample for metabolome analyse
arm group label: controls
arm group label: presymptomatic
arm group label: symptomatic
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christophe Verny, PU-PH
role: Principal Investigator
affiliation: University Hospital, Angers
last name: Christophe Verny, PU-PH
phone: 0241355615
email: Chverny@chu-angers.fr
last name: Dominique Bonneau, PU-PH
phone: 0241355615
email: dobonneau@chu-angers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Huntington Disease