<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/NCT02222285</url>
  </required_header>
  <id_info>
    <org_study_id>Vayarin_005</org_study_id>
    <nct_id>NCT02222285</nct_id>
  </id_info>
  <brief_title>An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)</brief_title>
  <official_title>An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enzymotec</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Enzymotec</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related&#xD;
      symptoms in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms</measure>
    <time_frame>over 14 weeks</time_frame>
    <description>A significant reduction from baseline to endpoint on the Aberrant Behavior Checklist (ABC) compared to patients administered placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Severity assesment</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Improvement assesment</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conners Rating Scale questionnaire</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Rating Inventory of Executive function</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health Questionnaire</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Strain Questionnaire</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events monitoring</measure>
    <time_frame>over 14 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Autistic Disorder</condition>
  <arm_group>
    <arm_group_label>Sequence 3: placebo/placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2: placebo/ Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin_005</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence one: Treatment/Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment/Treatment- consists of PS_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin_005</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Food : Vayarin_005</intervention_name>
    <arm_group_label>Sequence 2: placebo/ Treatment</arm_group_label>
    <arm_group_label>Sequence one: Treatment/Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Sequence 2: placebo/ Treatment</arm_group_label>
    <arm_group_label>Sequence 3: placebo/placebo</arm_group_label>
    <other_name>Cellulose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females, ages 6-17 inclusive&#xD;
&#xD;
          2. Must have a valid diagnosis of autism spectrum disorder via a clinical review of the&#xD;
             DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)&#xD;
&#xD;
          3. Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental&#xD;
             Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)&#xD;
&#xD;
          4. IQ &gt;50 evaluated by KBIT-2 or Stanford Binet Fifth Edition&#xD;
&#xD;
          5. Able, and likely to fully comply with the study procedures and instructions&#xD;
&#xD;
          6. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to&#xD;
             participate in the study provided they do not meet any exclusionary criteria.&#xD;
&#xD;
          7. Have normal physical examination and laboratory test results at screening. If&#xD;
             abnormal, the finding(s) must be deemed clinically insignificant by the study&#xD;
             Clinician.&#xD;
&#xD;
          8. Parents or legal guardian must be able to read, write and speak English&#xD;
&#xD;
          9. Parents or legal guardian have given written informed consent to participate in the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is significantly underweight under the 5th percentile or obese above the&#xD;
             95th percentile&#xD;
&#xD;
          2. Clinically significant systemic illness including hepatic, renal, gastroenterological,&#xD;
             metabolic, respiratory, cardiovascular (including ischemic heart disease),&#xD;
             endocrinologic, neurologic, immunologic, or hematologic disease, as determined by the&#xD;
             study clinician.&#xD;
&#xD;
          3. Patients with any primary psychiatric diagnosis other than autism at screening or a&#xD;
             known genetic syndrome(s) that cause autism.&#xD;
&#xD;
          4. Suspected or established CNS injury&#xD;
&#xD;
          5. Change in dosage of psychiatric pharmacotherapy or other medications that have central&#xD;
             nervous system effects or that affect performance 4 weeks before study initiation and&#xD;
             throughout the study phase&#xD;
&#xD;
          6. Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and&#xD;
             throughout the study&#xD;
&#xD;
          7. Use of dietary supplements, 60 days before study initiation and throughout the study&#xD;
&#xD;
          8. Change in educational/behavioral interventions within one month prior to participation&#xD;
             or during the study&#xD;
&#xD;
          9. A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or&#xD;
             substantial psychotic disorder.&#xD;
&#xD;
         10. Subject who has participated in another clinical trial within 30 days of screening for&#xD;
             this trial and/or any experimental treatment for this population&#xD;
&#xD;
         11. Current history of physical, sexual, or emotional abuse&#xD;
&#xD;
         12. History of alcohol or substance abuse as defined by DSM-IV criteria&#xD;
&#xD;
         13. Consumption of &gt;250 mg/day of caffeine&#xD;
&#xD;
         14. History of allergic reactions or sensitivity to marine products and soy&#xD;
&#xD;
         15. Has any illness which may jeopardize the participants' health or limit their&#xD;
             successful trial completion.&#xD;
&#xD;
         16. Any other reason that, in the opinion of the investigator, prevents the subject from&#xD;
             participating in the study or compromise the patient safety&#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>Eric Hollander, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spectrum Neuroscience and Treatment Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Neurology and Neurosurgery at St. Barnabas</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Neuroscience and Treatment Institute</name>
      <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>January 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</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>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Autistic Disorder</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/NCT02222285
org study id: Vayarin_005
nct id: NCT02222285
lead sponsor: 
has dmc: No
The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related
      symptoms in children.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms
time frame: over 14 weeks
description: A significant reduction from baseline to endpoint on the Aberrant Behavior Checklist (ABC) compared to patients administered placebo
measure: Clinical Global Impression of Severity assesment
time frame: over 14 weeks
measure: Clinical Global Impression of Improvement assesment
time frame: over 14 weeks
measure: Conners Rating Scale questionnaire
time frame: over 14 weeks
measure: Behavior Rating Inventory of Executive function
time frame: over 14 weeks
measure: Child Health Questionnaire
time frame: over 14 weeks
measure: Caregiver Strain Questionnaire
time frame: over 14 weeks
measure: Adverse events monitoring
time frame: over 14 weeks
arm group label: Sequence 3: placebo/placebo
arm group type: Placebo Comparator
description: Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment
arm group label: Sequence 2: placebo/ Treatment
arm group type: Active Comparator
description: Sequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin_005
arm group label: Sequence one: Treatment/Treatment
arm group type: Active Comparator
description: Treatment/Treatment- consists of PS_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin_005
intervention type: Other
intervention name: Medical Food : Vayarin_005
arm group label: Sequence 2: placebo/ Treatment
arm group label: Sequence one: Treatment/Treatment
intervention type: Other
intervention name: Placebo
arm group label: Sequence 2: placebo/ Treatment
arm group label: Sequence 3: placebo/placebo
other name: Cellulose
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Eric Hollander, M.D.
role: Principal Investigator
affiliation: Spectrum Neuroscience and Treatment Institute
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder
mesh term: Autistic Disorder