<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/NCT01696708</url>
  </required_header>
  <id_info>
    <org_study_id>C12-49</org_study_id>
    <secondary_id>2012-A01063-40</secondary_id>
    <nct_id>NCT01696708</nct_id>
  </id_info>
  <brief_title>Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease</brief_title>
  <acronym>PRO-MH2</acronym>
  <official_title>Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 brain energy profile evolution at different stages of&#xD;
      the Huntington disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr</measure>
    <time_frame>2 years</time_frame>
    <description>31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between primary outcome measure and clinical parameters</measure>
    <time_frame>2 years</time_frame>
    <description>Correlating a brain energy deficit with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study of longitudinal changes in Pi/PCr ratio over time.</measure>
    <time_frame>2 years</time_frame>
    <description>Patients will be retested after one month.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>31-Phosphorus RMN Spectroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>31-Phosphorus RMN Spectroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>31-Phosphorus RMN Spectroscopy</intervention_name>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UHDRS &lt; 50&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Ability to undergo MR scanning&#xD;
&#xD;
          -  Covered by french social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of psychiatric disorder&#xD;
&#xD;
          -  Attendant neurological disorder&#xD;
&#xD;
          -  Contraindications to MRI (claustrophobia, metallic or material implants)&#xD;
&#xD;
          -  Severe head injury&#xD;
&#xD;
          -  Unable to understand the protocol&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Failure to give informed consent&#xD;
&#xD;
          -  Subjects with exclusion criteria required by french law (e.g. subjects who require a&#xD;
             legally authorized representative to obtain consent)&#xD;
&#xD;
          -  Unwillingness to be informed in case of abnormal MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fanny Mochel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brain and Spine Institute (ICM)</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>March 8, 2017</last_update_submitted>
  <last_update_submitted_qc>March 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 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/NCT01696708
org study id: C12-49
secondary id: 2012-A01063-40
nct id: NCT01696708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to study brain energy profile evolution at different stages of
      the Huntington disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
time frame: 2 years
description: 31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate
measure: Correlation between primary outcome measure and clinical parameters
time frame: 2 years
description: Correlating a brain energy deficit with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).
measure: Study of longitudinal changes in Pi/PCr ratio over time.
time frame: 2 years
description: Patients will be retested after one month.
arm group label: Patients
arm group type: Other
description: 31-Phosphorus RMN Spectroscopy
arm group label: Volunteers
arm group type: Other
description: 31-Phosphorus RMN Spectroscopy
intervention type: Other
intervention name: 31-Phosphorus RMN Spectroscopy
arm group label: Patients
arm group label: Volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fanny Mochel, MD, PhD
role: Principal Investigator
affiliation: INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
facility: 
country: France
responsible party type: Sponsor
mesh term: Huntington Disease