<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/NCT01674010</url>
  </required_header>
  <id_info>
    <org_study_id>ELND005-BPD201</org_study_id>
    <secondary_id>2012-001935-30</secondary_id>
    <nct_id>NCT01674010</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder</brief_title>
  <official_title>A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OPKO Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Elan Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>OPKO Health, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine whether ELND005 is effective in the&#xD;
      maintenance treatment of bipolar 1 disorder when added to other therapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business Decision&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Emergent Adverse Events</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>The study was terminated early so no efficacy analysis was done, safety data are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Study Participants With Recurrence of Any Mood Episode</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recurrence of a Depressive Episode</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recurrence of a Manic/Hypomanic or a Mixed Episode</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">309</enrollment>
  <condition>Bipolar 1 Disorder</condition>
  <arm_group>
    <arm_group_label>Lamotrigine or Valproic acid + ELND005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lamotrigine or Valproic acid + placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ELND005</intervention_name>
    <arm_group_label>Lamotrigine or Valproic acid + ELND005</arm_group_label>
    <other_name>Scyllo-inositol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lamotrigine</intervention_name>
    <arm_group_label>Lamotrigine or Valproic acid + ELND005</arm_group_label>
    <arm_group_label>Lamotrigine or Valproic acid + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valproic acid</intervention_name>
    <arm_group_label>Lamotrigine or Valproic acid + ELND005</arm_group_label>
    <arm_group_label>Lamotrigine or Valproic acid + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Lamotrigine or Valproic acid + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit.&#xD;
&#xD;
          -  Has a history in the last 3 years of ≥ 1 manic or mixed episodes of sufficient&#xD;
             severity that required hospitalization and/or treatment with a mood stabilizer or&#xD;
             antipsychotic, or confirmed by a family member or medical records to ensure the&#xD;
             episode fulfills the DSM-IV-TR criteria.&#xD;
&#xD;
          -  Has experienced a mood episode of any polarity within 4 months prior to the Screening&#xD;
             Visit and responded to StOC therapy.&#xD;
&#xD;
          -  Is euthymic at the Screening Visit (ie, score of ≤ 12 on the MADRS and a score of ≤ 12&#xD;
             on the Y-MRS).&#xD;
&#xD;
          -  Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on&#xD;
             stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and&#xD;
             LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made&#xD;
             for tolerability reasons will be acceptable.&#xD;
&#xD;
        A study patient must meet the following additional criteria to be eligible for&#xD;
        randomization in the Double-blind Randomization Phase of this study:&#xD;
&#xD;
        - Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores&#xD;
        of ≤ 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be&#xD;
        allowed throughout Phase 1. Excursions are defined as Y-MRS or MADRS scores &gt;12 but ≤ 16.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Woman of childbearing potential who is unwilling or unable to use an acceptable method&#xD;
             of birth control or is using a prohibited contraceptive method.&#xD;
&#xD;
          -  Is found to be actively suicidal on the C-SSRS (answer of &quot;yes&quot; to question 4 or 5&#xD;
             [current or over the last 30 days]) or a score of ≥4 on the MADRS item 10 at the&#xD;
             Screening Visit.&#xD;
&#xD;
          -  Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone&#xD;
             (TSH) &gt;3 mIU/L at the Screening Visit.&#xD;
&#xD;
          -  Has received electroconvulsive therapy (ECT) during the current episode or within 6&#xD;
             months prior to the Screening Visit.&#xD;
&#xD;
          -  Has an estimated glomerular filtration rate &lt;40 mL/min/1.73 m2 according to the&#xD;
             Modification of Diet in Renal Disease formula.&#xD;
&#xD;
        A study patient who meets ANY of the above and ANY of the criteria below will not be&#xD;
        eligible for enrollment in the Double-blind Randomization Phase of this study:&#xD;
&#xD;
          -  Has current signs or symptoms of psychosis.&#xD;
&#xD;
          -  Has become actively suicidal as defined by C-SSRS answer of &quot;yes&quot; to question 4 or 5&#xD;
             (current or over the last 30 days) and/or has a score of ≥4 on MADRS item 10.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>National City</city>
        <state>California</state>
        <zip>91950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Oakland Park</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Fresh Meadows</city>
        <state>New York</state>
        <zip>11366</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Kardzhali</city>
        <zip>6600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Pazardzhik</city>
        <zip>4400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Vratsa</city>
        <zip>3000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6L 6W6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Chatham</city>
        <state>Ontario</state>
        <zip>N7M 5L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Praha</city>
        <zip>100 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Praha</city>
        <zip>120 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Praha</city>
        <zip>160 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Praha</city>
        <zip>18100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Strakonice</city>
        <zip>386 29</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Bully-Les-Mines</city>
        <zip>62160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Dole</city>
        <zip>39100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Elancourt</city>
        <zip>78990</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-156</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>91-229</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Tuszyn</city>
        <zip>95-080</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500366</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>041914</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Craiova</city>
        <zip>200473</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Sibiu</city>
        <zip>550082</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Torrevieja</city>
        <state>Alicante</state>
        <zip>03186</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Vitoria</city>
        <zip>01004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Diyarbakir</city>
        <zip>21280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elan Investigational Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Lithuania</country>
  </removed_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>September 14, 2015</results_first_submitted>
  <results_first_submitted_qc>September 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 12, 2015</results_first_posted>
  <last_update_submitted>October 17, 2019</last_update_submitted>
  <last_update_submitted_qc>October 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inositol</mesh_term>
    <mesh_term>Lamotrigine</mesh_term>
    <mesh_term>Valproic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Open Treatment Phase 1 ELND005 500 mg BID</title>
          <description>ELND005 500mg BID for 16 weeks</description>
        </group>
        <group group_id="P2">
          <title>Phase 2 Placebo</title>
          <description>Double Blind Randomization (Phase 2)</description>
        </group>
        <group group_id="P3">
          <title>Phase 2 ELND005 500 mg BID</title>
          <description>Randomization Phase 2 ELND005 500 mg BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open Treatment Phase 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not remain in a stable remission</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Randomization Phase 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="61"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Mood episode recurrence</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="45"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="309"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Phase 1(n=309)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.3" spread="11.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 2 Placebo (n=65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.5" spread="10.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 2 ELND005 500mg BID(n=64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.6" spread="10.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Phase 1 Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 1 Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 2 Placebo Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 2 Placebo Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 2 ELND005 500 BID Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phase 2 ELND005 500 BID Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic or Latino Phase 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino Phase 2 Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino Phase 2 ELND005 500 BID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino Phase 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino Phase 2 Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino Phase 2 ELND005 500 BID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown Phase 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown Phase 2 Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown Phase 2 ELND005 500 BID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>North America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Europe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment Emergent Adverse Events</title>
        <description>The study was terminated early so no efficacy analysis was done, safety data are reported.</description>
        <time_frame>up to 48 weeks</time_frame>
        <population>TEAEs reported for Phase 2 were from the entire study period</population>
        <group_list>
          <group group_id="O1">
            <title>Open Treatment Phase 1 ELND005 500 mg BID</title>
            <description>ELND005 500mg BID for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>Phase 2 Placebo</title>
            <description>Double Blind Randomization (Phase 2)</description>
          </group>
          <group group_id="O3">
            <title>Phase 2 ELND005 500 mg BID</title>
            <description>Randomization Phase 2 ELND005 500 mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Emergent Adverse Events</title>
          <description>The study was terminated early so no efficacy analysis was done, safety data are reported.</description>
          <population>TEAEs reported for Phase 2 were from the entire study period</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Study Participants With Recurrence of Any Mood Episode</title>
        <time_frame>up to 48 weeks</time_frame>
        <population>Study was prematurely terminated, no data were collected for this Outcome Measure</population>
        <group_list>
          <group group_id="O1">
            <title>Open Treatment Phase 1 ELND005 500 mg BID</title>
            <description>ELND005 500mg BID for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>Phase 2 Placebo</title>
            <description>Double Blind Randomization (Phase 2)</description>
          </group>
          <group group_id="O3">
            <title>Phase 2 ELND005 500 mg BID</title>
            <description>Randomization Phase 2 ELND005 500 mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Study Participants With Recurrence of Any Mood Episode</title>
          <population>Study was prematurely terminated, no data were collected for this Outcome Measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recurrence of a Depressive Episode</title>
        <time_frame>up to 48 weeks</time_frame>
        <population>Study was prematurely terminated, no data were collected for this Outcome Measure</population>
        <group_list>
          <group group_id="O1">
            <title>Open Treatment Phase 1 ELND005 500 mg BID</title>
            <description>ELND005 500mg BID for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>Phase 2 Placebo</title>
            <description>Double Blind Randomization (Phase 2)</description>
          </group>
          <group group_id="O3">
            <title>Phase 2 ELND005 500 mg BID</title>
            <description>Randomization Phase 2 ELND005 500 mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recurrence of a Depressive Episode</title>
          <population>Study was prematurely terminated, no data were collected for this Outcome Measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recurrence of a Manic/Hypomanic or a Mixed Episode</title>
        <time_frame>up to 48 weeks</time_frame>
        <population>Study was prematurely terminated, no data were collected for this Outcome Measure</population>
        <group_list>
          <group group_id="O1">
            <title>Open Treatment Phase 1 ELND005 500 mg BID</title>
            <description>ELND005 500mg BID for 16 weeks</description>
          </group>
          <group group_id="O2">
            <title>Phase 2 Placebo</title>
            <description>Double Blind Randomization (Phase 2)</description>
          </group>
          <group group_id="O3">
            <title>Phase 2 ELND005 500 mg BID</title>
            <description>Randomization Phase 2 ELND005 500 mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recurrence of a Manic/Hypomanic or a Mixed Episode</title>
          <population>Study was prematurely terminated, no data were collected for this Outcome Measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Open Treatment Phase 1 ELND005 500 mg BID</title>
          <description>ELND005 500mg BID for 16 weeks</description>
        </group>
        <group group_id="E2">
          <title>Phase 2 Placebo</title>
          <description>Double Blind Randomization (Phase 2)</description>
        </group>
        <group group_id="E3">
          <title>Phase 2 ELND005 500 mg BID</title>
          <description>Randomization Phase 2 ELND005 500 mg BID</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemolytic anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Food Poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bipolar I Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Impulsive Behaviour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="153" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury poisoning and procedural complications</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorders</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Aleksandra Pastrak,MD, PhD, VP of Clinical Development and Medical Officer</name_or_title>
      <organization>Transition Therapeutics Ireland Limited</organization>
      <phone>+1 416 263 1227</phone>
      <email>apastrak@transitiontherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01674010
org study id: ELND005-BPD201
secondary id: 2012-001935-30
nct id: NCT01674010
lead sponsor: 
collaborator: 
has dmc: Yes
The primary purpose of this study is to determine whether ELND005 is effective in the
      maintenance treatment of bipolar 1 disorder when added to other therapies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Treatment Emergent Adverse Events
time frame: up to 48 weeks
description: The study was terminated early so no efficacy analysis was done, safety data are reported.
measure: Proportion of Study Participants With Recurrence of Any Mood Episode
time frame: up to 48 weeks
measure: Time to Recurrence of a Depressive Episode
time frame: up to 48 weeks
measure: Time to Recurrence of a Manic/Hypomanic or a Mixed Episode
time frame: up to 48 weeks
arm group label: Lamotrigine or Valproic acid + ELND005
arm group type: Experimental
description: Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
arm group label: Lamotrigine or Valproic acid + placebo
arm group type: Placebo Comparator
description: Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
intervention type: Drug
intervention name: ELND005
arm group label: Lamotrigine or Valproic acid + ELND005
other name: Scyllo-inositol
intervention type: Drug
intervention name: Lamotrigine
arm group label: Lamotrigine or Valproic acid + ELND005
arm group label: Lamotrigine or Valproic acid + placebo
intervention type: Drug
intervention name: Valproic acid
arm group label: Lamotrigine or Valproic acid + ELND005
arm group label: Lamotrigine or Valproic acid + placebo
intervention type: Drug
intervention name: Placebo
arm group label: Lamotrigine or Valproic acid + placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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country: Bulgaria
country: Canada
country: Czechia
country: France
country: Poland
country: Romania
country: Spain
country: Turkey
country: United States
country: Czech Republic
country: Lithuania
responsible party type: Sponsor
mesh term: Inositol
mesh term: Lamotrigine
mesh term: Valproic Acid
participant flow: 
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certain agreements: 
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