<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/NCT03233867</url>
  </required_header>
  <id_info>
    <org_study_id>AEVI-001-ADHD-002</org_study_id>
    <nct_id>NCT03233867</nct_id>
  </id_info>
  <brief_title>A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations</brief_title>
  <official_title>A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aevi Genomic Medicine, LLC, a Cerecor company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avalo Therapeutics, Inc.</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>
      This is a non-interventional study in children and adolescents (ages 6-17 years) with&#xD;
      attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in&#xD;
      glutamatergic signaling and neuronal connectivity. The screening in this study will be&#xD;
      conducted through a combination of online and site performed activities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">August 3, 2018</completion_date>
  <primary_completion_date type="Actual">August 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2503</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects between the ages of 6 and 17 years, who have been told that they have ADHD, will&#xD;
        be eligible for screening.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parent/legally authorized representative (LAR) can speak and read English fluently,&#xD;
             have provided informed consent and agree to be contacted for an interventional study&#xD;
             prior to being genotyped.&#xD;
&#xD;
          2. Subject is 6 to 17 years of age (inclusive) at the time of informed consent.&#xD;
&#xD;
          3. Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor&#xD;
             that their child has ADHD.&#xD;
&#xD;
          4. Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parent/LAR confirms that the subject has been diagnosed with any of the following&#xD;
             conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression,&#xD;
             autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure&#xD;
             disorder, syncope, or other serious cardiac problems.&#xD;
&#xD;
          2. Aside from your child's current ADHD medication (if applicable), parent/LAR confirms&#xD;
             that the subject is currently taking any of the following medications:&#xD;
             antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers.&#xD;
&#xD;
          3. Parent/LAR confirms that the subject has been genotyped previously in the&#xD;
             MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Cutler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meridien Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aevi Genomic Medicine</name>
      <address>
        <city>Wayne</city>
        <state>Pennsylvania</state>
        <zip>19087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</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>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03233867
org study id: AEVI-001-ADHD-002
nct id: NCT03233867
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-interventional study in children and adolescents (ages 6-17 years) with
      attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in
      glutamatergic signaling and neuronal connectivity. The screening in this study will be
      conducted through a combination of online and site performed activities.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity
time frame: Day 1
Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Andrew Cutler, MD
role: Principal Investigator
affiliation: Meridien Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: Undecided