<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/NCT01733121</url>
  </required_header>
  <id_info>
    <org_study_id>NBI-98854-1202</org_study_id>
    <nct_id>NCT01733121</nct_id>
  </id_info>
  <brief_title>NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Tardive Dyskinesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurocrine Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurocrine Biosciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854&#xD;
      (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily&#xD;
      for the treatment of Tardive Dyskinesia (TD) symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-titration study to&#xD;
      evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to subject's optimal&#xD;
      dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a&#xD;
      total of 6 weeks of treatment. Approximately 90 medically stable male and female subjects&#xD;
      with one of the following clinical diagnoses will be enrolled: schizophrenia or&#xD;
      schizoaffective disorder with neuroleptic-induced TD; mood disorder with neuroleptic-induced&#xD;
      TD; or gastrointestinal disorder with metoclopramide-induced TD.&#xD;
&#xD;
      For subjects randomized to active treatment, the starting dose will be 25 mg NBI 98854, which&#xD;
      may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an&#xD;
      optimal dose of NBI-98854 for each subject&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6</measure>
    <time_frame>Week 6</time_frame>
    <description>Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AIMS Dyskinesia Total Score Change From Baseline at Week 6</measure>
    <time_frame>Week 6</time_frame>
    <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Tardive Dyskinesia</condition>
  <arm_group>
    <arm_group_label>NBI-98854</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NBI-98854</intervention_name>
    <description>25 mg capsule</description>
    <arm_group_label>NBI-98854</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NBI-98854</intervention_name>
    <description>50 mg capsule</description>
    <arm_group_label>NBI-98854</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have one of the following clinical diagnoses for at least 3 months prior to screening&#xD;
             a) schizophrenia or schizoaffective disorder; b) mood disorder; or c) gastrointestinal&#xD;
             disorder (e.g., gastroparesis, gastroesophageal reflux disease)&#xD;
&#xD;
          -  Have a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3&#xD;
             months prior to screening.&#xD;
&#xD;
          -  Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before&#xD;
             study start. Subjects who are not using antipsychotic medication must have stable&#xD;
             psychiatric status.&#xD;
&#xD;
          -  Have the doses of concurrent medications and the conditions being treated be stable&#xD;
             for a minimum of 30 days before study start and be expected to remain stable during&#xD;
             the study.&#xD;
&#xD;
          -  Subjects of childbearing potential must agree to use hormonal or two forms of&#xD;
             nonhormonal birth control during the study.&#xD;
&#xD;
          -  Female subjects must not be pregnant.&#xD;
&#xD;
          -  Be in good general health and expected to complete the clinical study as designed.&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).&#xD;
&#xD;
          -  Have a negative urine drug screen (negative for amphetamines, barbiturates,&#xD;
             benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and&#xD;
             study start, except for any subject receiving a stable dose of benzodiazepine.&#xD;
&#xD;
          -  Have a negative alcohol breath test at screening and study start.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an active clinically significant unstable medical condition within 1 month (30&#xD;
             days) prior to screening.&#xD;
&#xD;
          -  Have a history of substance dependence or substance (drug) or alcohol abuse within the&#xD;
             3 months before study start(nicotine and caffeine dependence are not exclusionary).&#xD;
&#xD;
          -  Have a known history of neuroleptic malignant syndrome.&#xD;
&#xD;
          -  Have a significant risk of suicidal or violent behavior.&#xD;
&#xD;
          -  Receiving any excluded concomitant medication such as reserpine, metoclopramide,&#xD;
             stimulants, or tetrabenazine.&#xD;
&#xD;
          -  Receiving medication for the treatment of tardive dyskinesia.&#xD;
&#xD;
          -  Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface&#xD;
             antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a&#xD;
             history of positive result.&#xD;
&#xD;
          -  Have received an investigational drug within 30 days before screening or plan to use&#xD;
             an investigational drug (other than NBI-98854) during the study.&#xD;
&#xD;
          -  Have an allergy, hypersensitivity, or intolerance to tetrabenazine.&#xD;
&#xD;
          -  Have had previous exposure with NBI-98854.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris O'Brien, MD</last_name>
    <role>Study Director</role>
    <affiliation>Neurocrine Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Conshohocken</city>
        <state>Pennsylvania</state>
        <zip>19428</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenixville</city>
        <state>Pennsylvania</state>
        <zip>19460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>DeSoto</city>
        <state>Texas</state>
        <zip>75115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richland</city>
        <state>Washington</state>
        <zip>99352</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caguas</city>
        <zip>00725</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>May 11, 2017</results_first_submitted>
  <results_first_submitted_qc>July 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2017</results_first_posted>
  <disposition_first_submitted>November 20, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>November 20, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 10, 2014</disposition_first_posted>
  <last_update_submitted>July 11, 2017</last_update_submitted>
  <last_update_submitted_qc>July 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</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>Dyskinesias</mesh_term>
    <mesh_term>Tardive Dyskinesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetrabenazine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study enrolled patients with schizophrenia or schizoaffective disorder with tardive dyskinesia (TD), a mood disorder with TD, or a GI disorder with TD from 29 centers in the United States and Puerto Rico. The last patient completed in December 2013.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Valbenazine</title>
          <description>Participants could receive valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks); flexible dose escalation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blind Period (Week 0 to 6)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-Up Period (Week 6 to 8)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set (all randomized subjects who received at least one dose of study drug).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Valbenazine</title>
          <description>Participants received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.6" lower_limit="34" upper_limit="78"/>
                    <measurement group_id="B2" value="56.7" lower_limit="32" upper_limit="78"/>
                    <measurement group_id="B3" value="56.2" lower_limit="32" upper_limit="78"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="57"/>
                  </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>
              <title>American Indian/Alaska native</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/Alaska native, Caucasian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other/mixed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.19" lower_limit="18.0" upper_limit="38.3"/>
                    <measurement group_id="B2" value="29.02" lower_limit="18.1" upper_limit="42.0"/>
                    <measurement group_id="B3" value="28.62" lower_limit="18.0" upper_limit="42.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Schizophrenia or schizoaffective disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mood disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gastrointestinal disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at TD Diagnosis</title>
          <population>Date of diagnosis was not available for some subjects.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="36"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.5" lower_limit="23" upper_limit="77"/>
                    <measurement group_id="B2" value="48.9" lower_limit="25" upper_limit="70"/>
                    <measurement group_id="B3" value="49.2" lower_limit="23" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BPRS Total Score</title>
          <description>The Brief Psychiatric Rating Scale (BPRS) is a clinician-rated tool designed to assess change in the severity of psychopathology in patients with schizophrenia and other psychotic disorders (Overall and Gorham, 1962, 1988). The severity of each of the 18 items of the BPRS is rated on a scale of 1 (not present) to 7 (extremely severe) (total score range: 18 to 126). Higher scores represent greater symptom severity.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.1" lower_limit="19" upper_limit="49"/>
                    <measurement group_id="B2" value="30.1" lower_limit="19" upper_limit="48"/>
                    <measurement group_id="B3" value="30.1" lower_limit="19" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline AIMS Total Dyskinesia Score</title>
          <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
          <population>Includes subjects with a central video raters' AIMS dyskinesia total score change from baseline value at Week 6</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="44"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.9" spread="4.5"/>
                    <measurement group_id="B2" value="8.0" spread="3.5"/>
                    <measurement group_id="B3" value="8.0" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6</title>
        <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Valbenazine</title>
            <description>Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6</title>
          <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
          <population>Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.1"/>
                    <measurement group_id="O2" value="-3.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6</title>
        <description>Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).</description>
        <time_frame>Week 6</time_frame>
        <population>Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Valbenazine</title>
            <description>Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6</title>
          <description>Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).</description>
          <population>Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.5" upper_limit="3.6"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.6" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AIMS Dyskinesia Total Score Change From Baseline at Week 6</title>
        <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
        <time_frame>Week 6</time_frame>
        <population>Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received Placebo capsule (matching NBI-98854 capsules) once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NBI-98854</title>
            <description>Participants first received NBI-98854 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>AIMS Dyskinesia Total Score Change From Baseline at Week 6</title>
          <description>The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.</description>
          <population>Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-2.4" upper_limit="2.0"/>
                    <measurement group_id="O2" value="-2.6" lower_limit="-4.9" upper_limit="-0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6</title>
        <description>Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).</description>
        <time_frame>Week 6</time_frame>
        <population>Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Valbenazine</title>
            <description>Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6</title>
          <description>Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).</description>
          <population>Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.5" upper_limit="3.6"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.7" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks followed by 2 weeks posttreatment period.</description>
        </group>
        <group group_id="E2">
          <title>Valbenazine</title>
          <description>Participants first received valbenazine 5mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks) followed by 2 weeks posttreatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Non-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="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Non-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="11" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </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>Generally, the PI has the right to publish results provided such publication does not violate confidentiality or IP provisions within the contract with the Sponsor. Prior to submission for publication or presentation of results, the PI must provide the Sponsor time for review. The Sponsor can request the PI to withhold or remove information from all publications. For a multi-center study, any publication of results by the PI shall not be made before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Neurocrine Medical Information</name_or_title>
      <organization>Neurocrine Biosciences, Inc.</organization>
      <phone>877-641-3461</phone>
      <email>medinfo@neurocrine.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/NCT01733121
org study id: NBI-98854-1202
nct id: NCT01733121
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily
      for the treatment of Tardive Dyskinesia (TD) symptoms.
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-titration study to
      evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to subject's optimal
      dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a
      total of 6 weeks of treatment. Approximately 90 medically stable male and female subjects
      with one of the following clinical diagnoses will be enrolled: schizophrenia or
      schizoaffective disorder with neuroleptic-induced TD; mood disorder with neuroleptic-induced
      TD; or gastrointestinal disorder with metoclopramide-induced TD.

      For subjects randomized to active treatment, the starting dose will be 25 mg NBI 98854, which
      may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an
      optimal dose of NBI-98854 for each subject
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6
time frame: Baseline and Week 6
description: The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
measure: Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6
time frame: Week 6
description: Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
measure: AIMS Dyskinesia Total Score Change From Baseline at Week 6
time frame: Week 6
description: The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
arm group label: NBI-98854
arm group type: Experimental
description: Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
intervention type: Drug
intervention name: NBI-98854
description: 25 mg capsule
arm group label: NBI-98854
intervention type: Drug
intervention name: NBI-98854
description: 50 mg capsule
arm group label: NBI-98854
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Chris O'Brien, MD
role: Study Director
affiliation: Neurocrine Biosciences
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Dyskinesias
mesh term: Tardive Dyskinesia
mesh term: Tetrabenazine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 