<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/NCT02243475</url>
  </required_header>
  <id_info>
    <org_study_id>PROPANE STUDY</org_study_id>
    <nct_id>NCT02243475</nct_id>
  </id_info>
  <brief_title>Probing the Role of Sodium Channels in Painful Neuropathies</brief_title>
  <official_title>Probing the Role of Sodium Channels in Painful Neuropathies: Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deutsche Diabetes Gesellschaft</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre National de la Recherche Scientifique, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ospedale San Raffaele</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact&#xD;
      on patients' quality of life and health care costs. Not all individuals with neuropathy&#xD;
      develop pain and it is not possible to predict who is more or less susceptible among those&#xD;
      with similar risk exposure. Current inability to identify high-risk individuals hinders&#xD;
      development and application of therapies to counteract neuropathic pain and to address&#xD;
      targeted prevention strategies. Recently, the investigators Consortium has identified novel&#xD;
      pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to&#xD;
      play a critical role in the generation and conduction of action potentials in nociceptors and&#xD;
      their terminal axons. This study was undertaken in a carefully selected group of patients&#xD;
      with painful neuropathy using a candidate gene approach and directly revealed targets for new&#xD;
      therapeutic strategies. This discover widened the spectrum of sodium channel-related pain&#xD;
      disorders including conditions more common in the general population than those known so far.&#xD;
      PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a&#xD;
      cohort of patients with predominantly small fibre neuropathy, aims to develop this original&#xD;
      idea in a larger and well characterized study population, to provide evidence for the&#xD;
      reliable stratification of patients at high risk and potential new treatments tailored on&#xD;
      patients' clinical features, in order to improve their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6, and Nav1.3 sodium channels</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Painful Peripheral Neuropathy</condition>
  <condition>Painless Peripheral Neuropathy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      identification of novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6,&#xD;
      and Nav1.3 sodium channels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        homogeneous cohorts of patients (age &gt;18 years) with painful and painless diabetic or&#xD;
        idiopathic sensory neuropathy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of sensory neuropathy, including pure small fibre neuropathy (SFN), based on&#xD;
             established clinical, nerve conduction study (NCS) and skin biopsy findings (Tesfaye&#xD;
             et al. Diab Care 2010) caused by&#xD;
&#xD;
               1. type 1 or type 2 diabetes (World Health Organization criteria) with stable&#xD;
                  metabolic control for &gt;6 months (haemoglobin A1C &lt;9%); or&#xD;
&#xD;
               2. idiopathic aetiology after ruling out all known causes of neuropathy including&#xD;
                  vitamin deficiencies, malignancies, toxic, drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any other cause of neuropathy&#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>Giuseppe Lauria, MD</last_name>
    <role>Study Chair</role>
    <affiliation>FINCB</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</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>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>December 2, 2016</submitted>
    <returned>January 26, 2017</returned>
  </pending_results>
  <!-- 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/NCT02243475
org study id: PROPANE STUDY
nct id: NCT02243475
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact
      on patients' quality of life and health care costs. Not all individuals with neuropathy
      develop pain and it is not possible to predict who is more or less susceptible among those
      with similar risk exposure. Current inability to identify high-risk individuals hinders
      development and application of therapies to counteract neuropathic pain and to address
      targeted prevention strategies. Recently, the investigators Consortium has identified novel
      pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to
      play a critical role in the generation and conduction of action potentials in nociceptors and
      their terminal axons. This study was undertaken in a carefully selected group of patients
      with painful neuropathy using a candidate gene approach and directly revealed targets for new
      therapeutic strategies. This discover widened the spectrum of sodium channel-related pain
      disorders including conditions more common in the general population than those known so far.
      PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a
      cohort of patients with predominantly small fibre neuropathy, aims to develop this original
      idea in a larger and well characterized study population, to provide evidence for the
      reliable stratification of patients at high risk and potential new treatments tailored on
      patients' clinical features, in order to improve their quality of life.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6, and Nav1.3 sodium channels
time frame: 2 years
identification of novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6,
      and Nav1.3 sodium channels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giuseppe Lauria, MD
role: Study Chair
affiliation: FINCB
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Pain
submitted: December 2, 2016
returned: January 26, 2017