<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/NCT01706523</url>
  </required_header>
  <id_info>
    <org_study_id>209AS209</org_study_id>
    <nct_id>NCT01706523</nct_id>
  </id_info>
  <brief_title>Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders</brief_title>
  <official_title>An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seaside Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seaside Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label extension protocol that will provide necessary data on the safety,&#xD;
      tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label extension study enrolling by invitation only to those subjects that&#xD;
      have completed Seaside protocols 209AS208 and 22007.&#xD;
&#xD;
      Protocol 209AS208, &quot;A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy,&#xD;
      Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social&#xD;
      Withdrawal in Subjects with Autism Spectrum Disorders.&quot;&#xD;
&#xD;
      Protocol 22007, &quot;An Open Label Extension Study to Evaluate the Safety, Tolerability and&#xD;
      Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder.&quot;&#xD;
&#xD;
      This open-label extension will provide data on the following:&#xD;
&#xD;
        1. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)&#xD;
&#xD;
        2. Provide supporting pharmacokinetic analyses&#xD;
&#xD;
        3. Assess long term efficacy on social behaviors in subjects with ASD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of STX209</measure>
    <time_frame>100 weeks</time_frame>
    <description>Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aberrant Behavior Checklist</measure>
    <time_frame>100 weeks</time_frame>
    <description>Open-label assessment of change from baseline on the ABC</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">165</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>STX209</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active treatment with STX209</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STX209 (arbaclofen)</intervention_name>
    <description>Long-term, daily, orally-administered STX209</description>
    <arm_group_label>STX209</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject completed study 22007 or 209AS208, and showed he can adequately follow the&#xD;
             protocol, and with adequate medical justification to enter this study.&#xD;
&#xD;
          -  Parent or other legally-authorized representative or caregiver is willing and able to&#xD;
             perform all protocol-specified functions.&#xD;
&#xD;
          -  Treatment with no more than 2 psychoactive medications&#xD;
&#xD;
          -  Subjects with a history of seizure disorder must be adequately well-controlled, as&#xD;
             specified in the study protocol&#xD;
&#xD;
          -  For female subjects, negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid conditions that might interfere with the conduct of the study or confound the&#xD;
             interpretation of the study data, or endanger the subject.&#xD;
&#xD;
          -  Current use of illicit drugs or alcohol abuse.&#xD;
&#xD;
          -  Subjects with a serious adverse event or other adverse event in study 22007 or&#xD;
             209AS208 that was related to STX209, and that endangers the subject, in the opinion of&#xD;
             the investigator&#xD;
&#xD;
          -  Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Wang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Seaside Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwest Autism Research &amp; Resource Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California-Los Angeles Neuropsychiatric Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCDavis M.I.N.D Insitute</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmax Research Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Mary Pediatrics</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Behavioral Medicine</name>
      <address>
        <city>Smyrna</city>
        <state>Georgia</state>
        <zip>30080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Juvenile Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennedy Krieger Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri, Thompson Research Center for Autism &amp; Neurodevelopmental Disorders</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seaver Autism Center, Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYS Institute for Basic Research in Developmental Disabilities</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Chapel Hill Department of Psychiatry</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akron Children's Hospital</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cutting Edge Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Research Associates</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Group, LeBonheur Children's Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Kennedy Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Red Oaks Psychiatry Associates, P.A.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Road Runner Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>July 30, 2013</last_update_submitted>
  <last_update_submitted_qc>July 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism Spectrum Disorders</keyword>
  <keyword>Autism</keyword>
  <keyword>Asperger</keyword>
  <keyword>Pervasive Developmental Disorder - Not otherwise specified</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT01706523
org study id: 209AS209
nct id: NCT01706523
lead sponsor: 
has dmc: Yes
This is an open-label extension protocol that will provide necessary data on the safety,
      tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
This is an open label extension study enrolling by invitation only to those subjects that
      have completed Seaside protocols 209AS208 and 22007.

      Protocol 209AS208, "A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy,
      Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social
      Withdrawal in Subjects with Autism Spectrum Disorders."

      Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and
      Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."

      This open-label extension will provide data on the following:

        1. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)

        2. Provide supporting pharmacokinetic analyses

        3. Assess long term efficacy on social behaviors in subjects with ASD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of STX209
time frame: 100 weeks
description: Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
measure: Aberrant Behavior Checklist
time frame: 100 weeks
description: Open-label assessment of change from baseline on the ABC
arm group label: STX209
arm group type: Experimental
description: Active treatment with STX209
intervention type: Drug
intervention name: STX209 (arbaclofen)
description: Long-term, daily, orally-administered STX209
arm group label: STX209
criteria: 
gender: All
minimum age: 5 Years
maximum age: 21 Years
healthy volunteers: No
last name: Paul Wang, M.D.
role: Study Director
affiliation: Seaside Therapeutics, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive