<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/NCT02192099</url>
  </required_header>
  <id_info>
    <org_study_id>GLYX13-C-203</org_study_id>
    <nct_id>NCT02192099</nct_id>
  </id_info>
  <brief_title>Open Label Extension for GLYX13-C-202, NCT01684163</brief_title>
  <official_title>Phase 2, Open Label Extension for Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder Previously Treated With GLYX-13 (Extension of GLYX13-C-202, NCT01684163)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naurex, Inc, an affiliate of Allergan plc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naurex, Inc, an affiliate of Allergan plc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in&#xD;
      GLYX13-C-202.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in&#xD;
      GLYX13-C-202 in an open label extension trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Patients from this study were rolled into RAP-MD-99.&#xD;
  </why_stopped>
  <start_date type="Actual">September 8, 2014</start_date>
  <completion_date type="Actual">November 8, 2018</completion_date>
  <primary_completion_date type="Actual">November 8, 2018</primary_completion_date>
  <phase>Phase 2</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>The Number of Participants Who Experience an Adverse Event Over the Course of the Study.</measure>
    <time_frame>48 Months</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Rapastinel (225 mg/450 mg IV administration) prefilled syringe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rapastinel (225 mg/450 mg IV administration)</intervention_name>
    <description>Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel</description>
    <arm_group_label>Rapastinel (225 mg/450 mg IV administration) prefilled syringe</arm_group_label>
    <other_name>GLYX-13 IV Dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants who have completed 8 weeks of treatment in the preceding study&#xD;
             (GLYX13-C-202, NCT01684163.&#xD;
&#xD;
          2. Participants who wish to continue treatment with GLYX-13 after the preceding study.&#xD;
&#xD;
          3. Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR)&#xD;
             criteria for major depressive disorder (MDD).&#xD;
&#xD;
          4. Female subjects of childbearing potential with a negative serum pregnancy test prior&#xD;
             to entry into the study and who are practicing an adequate method of birth control (eg&#xD;
             oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who&#xD;
             do not plan to become pregnant during the course of the study. Female subjects may be&#xD;
             included without a negative serum pregnancy test if they are surgically sterile or at&#xD;
             least 2 years post-menopausal.&#xD;
&#xD;
          5. Clinical laboratory values &lt;2 times the upper limit of normal (ULN) or deemed not&#xD;
             clinically significant per the investigator and Naurex medical monitor.&#xD;
&#xD;
          6. Ability to understand the requirements of the study, provide written informed consent,&#xD;
             abide by the study restrictions, and agree to return for the required assessments.&#xD;
&#xD;
          7. Based on the investigator and Naurex medical monitor's clinical judgment, subjects&#xD;
             with eating disorders, obsessive compulsive disorder (OCD), panic disorder,&#xD;
             post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to&#xD;
             major depressive episodes (MDEs) are permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Axis I diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive&#xD;
             disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating&#xD;
             disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder,&#xD;
             acute stress disorder, agoraphobia, social phobia, attention-deficit hyperactivity&#xD;
             disorder (ADHD), or PTSD.&#xD;
&#xD;
          2. A clinically significant current Axis II diagnosis of borderline, antisocial,&#xD;
             paranoid, schizoid, schizotypal, or histrionic personality disorder&#xD;
&#xD;
          3. Experiencing hallucinations, delusions, or any psychotic symptomatology in the current&#xD;
             episode; lifetime history of psychosis.&#xD;
&#xD;
          4. Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures&#xD;
             or strokes.&#xD;
&#xD;
          5. Currently hospitalized or residing in an in-patient facility during study&#xD;
             participation.&#xD;
&#xD;
          6. Substance abuse since the end of participation in GLYX13-C-202, including greater than&#xD;
             or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine&#xD;
             4 oz, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator&#xD;
&#xD;
          7. Women who are planning to become pregnant during the course of the study.&#xD;
&#xD;
          8. Allergy or intolerance to current antidepressant or other current medications.&#xD;
&#xD;
          9. Participation in any clinical trial of an investigational product or device within 30&#xD;
             days of enrollment in this trial with the exception of GLYX13-C-202.&#xD;
&#xD;
         10. Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other&#xD;
             agent that in the opinion of the investigator is being abused&#xD;
&#xD;
         11. Pose current (past 6 months) suicide risk based on administration of the C SSRS and&#xD;
             the investigator's clinical judgment.&#xD;
&#xD;
         12. Human immunodeficiency virus (HIV) infection (based on the based on the HIV-1 &amp; HIV-2&#xD;
             antibody screen) or other ongoing infectious disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenna Hoogerheyde</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Office of Psychiatric Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas School of Medicine Clinical Trial Unit</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PharmaSite Research, Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Clinical Trials Inc.</name>
      <address>
        <city>Roslindale</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodlands Professional Princeton Medical Institute Building</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lake Clinical Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center of HOPE</name>
      <address>
        <city>Mason</city>
        <state>Ohio</state>
        <zip>45040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences Phase 2/3 Outpatient &amp; CNS Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <results_first_submitted>November 8, 2019</results_first_submitted>
  <results_first_submitted_qc>November 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2019</results_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</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>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 23, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02192099/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02192099/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Outpatients who have completed 8 or more weeks of treatment in the preceding study (GLYX13-C-202) and were willing to continue treatment with rapastinel (GLYX-13). Patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rapastinel (GLYX-13) 225mg or 450 mg IV Administration</title>
          <description>Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" 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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous Reasons</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Population will consist of all subjects who received any injection of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Rapastinel (GLYX-13) 225mg or 450 mg IV Administration</title>
          <description>Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.4" spread="10.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Who Experience an Adverse Event Over the Course of the Study.</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.</description>
        <time_frame>48 Months</time_frame>
        <population>The Safety Population will consist of all subjects who received any injection of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Rapastinel (GLYX-13) 225mg or 450 mg IV Administration</title>
            <description>Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Who Experience an Adverse Event Over the Course of the Study.</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.</description>
          <population>The Safety Population will consist of all subjects who received any injection of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected for up to 48 months.</time_frame>
      <desc>The Safety Population will consist of all subjects who received any injection of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rapastinel (GLYX-13) 225mg or 450 mg IV Administration</title>
          <description>Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Volvulus of small bowel</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Delayed recovery from anaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Ureteric injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Glioblastoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Lacunar stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Drug use disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
              </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>A 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 less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>IR-CTRegistration@allergan.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/NCT02192099
org study id: GLYX13-C-203
nct id: NCT02192099
lead sponsor: 
has dmc: No
Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in
      GLYX13-C-202.
Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in
      GLYX13-C-202 in an open label extension trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
time frame: 48 Months
description: An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.
arm group label: Rapastinel (225 mg/450 mg IV administration) prefilled syringe
arm group type: Experimental
description: Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel
intervention type: Drug
intervention name: Rapastinel (225 mg/450 mg IV administration)
description: Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel
arm group label: Rapastinel (225 mg/450 mg IV administration) prefilled syringe
other name: GLYX-13 IV Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jenna Hoogerheyde
role: Study Director
affiliation: Allergan
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 