<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/NCT01669889</url>
  </required_header>
  <id_info>
    <org_study_id>BP28421</org_study_id>
    <nct_id>NCT01669889</nct_id>
  </id_info>
  <brief_title>A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome</brief_title>
  <official_title>A Multi-center, Non-drug Study to Explore the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multi-center, non-drug study will explore the relationship between exploratory&#xD;
      biomarkers and functional dimensions in male adult individuals with Autistic Disorder or&#xD;
      Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of&#xD;
      assessments on study visit Day 1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Behavior assessment ratings</measure>
    <time_frame>approximately 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition assessment ratings</measure>
    <time_frame>approximately 5 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>Healthy Volunteer, Autistic Disorder, Asperger's Syndrome</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        High functioning (IQ &gt;70) male adult individuals with Autistic Disorder or Asperger's&#xD;
        Syndrome and age and IQ matched healthy male volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals with Autistic Disorder or Asperger's Syndrome:&#xD;
&#xD;
          -  Male adults, 18 to 45 years of age inclusive&#xD;
&#xD;
          -  Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV&#xD;
&#xD;
          -  IQ &gt;70&#xD;
&#xD;
          -  Body mass index (BMI) 18 to 35 kg/m2&#xD;
&#xD;
          -  Availability of a reliable caregiver, able and willing to provide information&#xD;
             regarding the individual's behavior and symptoms&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
          -  Healthy male adults, 18 to 45 years of age inclusive&#xD;
&#xD;
          -  IQ &gt;70&#xD;
&#xD;
          -  Body mass index (BMI) 18 to 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General exclusion criteria:&#xD;
&#xD;
          -  Positive test for drugs of abuse or alcohol&#xD;
&#xD;
          -  Confirmed systolic blood pressure &gt;140 or &lt;90 mmHg, and diastolic blood pressure &gt;90&#xD;
             or &lt;50 mmHg&#xD;
&#xD;
          -  Resting pulse rate &gt;100 or &lt;40 beats per minute&#xD;
&#xD;
          -  Alcohol and/or substance abuse/dependence during the last 12 months&#xD;
&#xD;
          -  Concomitant disease or condition that could interfere with, or treatment of which&#xD;
             might interfere with, the conduct of the study, or that would, in the opinion of the&#xD;
             investigator, pose an unacceptable risk to the subject in this study&#xD;
&#xD;
        Additionally for individuals with Autistic Disorder or Asperger's Syndrome:&#xD;
&#xD;
          -  History of epilepsy/seizure disorder (except simple febrile seizures)&#xD;
&#xD;
               -  Significant disruptive, aggressive or self-injurious, or sexually inappropriate&#xD;
                  behavior during the last 3 months that in the opinion of the investigator might&#xD;
                  interfere with the conduct of the study&#xD;
&#xD;
        Additionally for healthy controls:&#xD;
&#xD;
          -  Clinically significant abnormalities in laboratory test results&#xD;
&#xD;
          -  History of or current psychiatric, neurological disorder or pervasive developmental&#xD;
             disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Los Ageles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</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>Syndrome</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Asperger Syndrome</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/NCT01669889
org study id: BP28421
nct id: NCT01669889
lead sponsor: 
This multi-center, non-drug study will explore the relationship between exploratory
      biomarkers and functional dimensions in male adult individuals with Autistic Disorder or
      Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of
      assessments on study visit Day 1.
observational model: Cohort
time perspective: Prospective
measure: Behavior assessment ratings
time frame: approximately 5 months
measure: Cognition assessment ratings
time frame: approximately 5 months
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Autistic Disorder
mesh term: Asperger Syndrome