<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/NCT02989792</url>
  </required_header>
  <id_info>
    <org_study_id>T1001-03</org_study_id>
    <nct_id>NCT02989792</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain</brief_title>
  <official_title>A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tools4Patient</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tools4Patient</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>
      Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling&#xD;
      for genotyping purposes. In addition they will compete the personality questionnaires they&#xD;
      had completed in the former trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">October 5, 2017</completion_date>
  <primary_completion_date type="Actual">October 5, 2017</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with SNPs variation of monoamine oxidase</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with SNPs variation of dopamine B hydroxylase</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with SNPs variation of dopamine receptor 3</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with SNPs variation of brain-derived neurotropic factor genes</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SNPs variation of tryptophan hydroxylase-2</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SNPs variation of 5-hydroxytryptamine transporter</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SNPs variation of opioid receptor gene</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SNPs variation of fatty acid amid hydrolase gene</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>SNPs will be analyzed with Sanger based genotyping or equivalent method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones</measure>
    <time_frame>Time zero equals baseline</time_frame>
    <description>Cronbach's alpha between 0 and 1</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Peripheral Neuropathy</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Unique study arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Blood sampling for genotyping</intervention_name>
    <description>Venous punction of maximum 10 millilitres</description>
    <arm_group_label>Unique study arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personality Questionnaires completion</intervention_name>
    <description>Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires</description>
    <arm_group_label>Unique study arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have completed T1001-01 or T1001-02 study (Visit 5 completed)&#xD;
&#xD;
          -  are men or women of at least 18 years of age&#xD;
&#xD;
          -  have given written informed consent approved by the relevant Ethics Committee&#xD;
             governing the study sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have any close relationship with the Investigators or the Sponsor&#xD;
&#xD;
          -  are under legal protection, according to the national law&#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>Alvaro Pereira</last_name>
    <role>Study Director</role>
    <affiliation>Tools4Patient</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ATC SA</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIC Clermont-Ferrand CHU G. Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eurofins Optimed</name>
      <address>
        <city>Gieres</city>
        <zip>38610</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Chronic Pain</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/NCT02989792
org study id: T1001-03
nct id: NCT02989792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling
      for genotyping purposes. In addition they will compete the personality questionnaires they
      had completed in the former trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of monoamine oxidase
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of dopamine B hydroxylase
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of dopamine receptor 3
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of brain-derived neurotropic factor genes
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of tryptophan hydroxylase-2
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of 5-hydroxytryptamine transporter
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of opioid receptor gene
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Number of participants with SNPs variation of fatty acid amid hydrolase gene
time frame: Time zero equals baseline
description: SNPs will be analyzed with Sanger based genotyping or equivalent method
measure: Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones
time frame: Time zero equals baseline
description: Cronbach's alpha between 0 and 1
arm group label: Unique study arm
arm group type: Other
intervention type: Genetic
intervention name: Blood sampling for genotyping
description: Venous punction of maximum 10 millilitres
arm group label: Unique study arm
intervention type: Other
intervention name: Personality Questionnaires completion
description: Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires
arm group label: Unique study arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alvaro Pereira
role: Study Director
affiliation: Tools4Patient
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Chronic Pain