<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/NCT04400331</url>
  </required_header>
  <id_info>
    <org_study_id>NBI-98854-HD3006</org_study_id>
    <nct_id>NCT04400331</nct_id>
  </id_info>
  <brief_title>Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease</brief_title>
  <official_title>Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurocrine Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huntington Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neurocrine Biosciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of&#xD;
      valbenazine, and to provide participants continued access to valbenazine for the treatment of&#xD;
      chorea associated with Huntington disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to 156 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score</measure>
    <time_frame>Up to 156 weeks</time_frame>
    <description>The TMC is part of the motor assessment of the UHDRS and measures chorea in 7 different body parts including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. A decrease in score indicates improvement in chorea.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Chorea, Huntington</condition>
  <arm_group>
    <arm_group_label>Valbenazine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule, administered orally once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valbenazine</intervention_name>
    <description>vesicular monoamine transporter 2 (VMAT2) inhibitor</description>
    <arm_group_label>Valbenazine</arm_group_label>
    <other_name>NBI-98854</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Either #1 or #2 must be met for inclusion eligibility.&#xD;
&#xD;
          1. Have participated in Study NBI-98854-HD3005 and&#xD;
&#xD;
             a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by&#xD;
             completed study drug dosing through the follow-up visit or early terminated Study&#xD;
             NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure&#xD;
             related to COVID-19)&#xD;
&#xD;
          2. Did not participate in Study NBI-98854-HD3005 and&#xD;
&#xD;
               1. Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea&#xD;
&#xD;
               2. Be able to walk, with or without the assistance of a person or device&#xD;
&#xD;
          3. Be able to read and understand English and capable of providing consent to study&#xD;
             participation or have a legally authorized representative providing consent and the&#xD;
             participant providing assent&#xD;
&#xD;
          4. Participants of childbearing potential must agree to use contraception consistently&#xD;
             while participating in the study until 30 days after last dose of the study treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have difficulty swallowing&#xD;
&#xD;
          2. Are currently pregnant or breastfeeding&#xD;
&#xD;
          3. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch&#xD;
             block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure&#xD;
&#xD;
          4. Have an unstable or serious medical or psychiatric illness&#xD;
&#xD;
          5. Have a significant risk of suicidal behavior&#xD;
&#xD;
          6. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1&#xD;
             year of screening&#xD;
&#xD;
          7. Have received gene therapy at any time&#xD;
&#xD;
          8. Have received an investigational drug in a clinical study (other than valbenazine)&#xD;
             within 30 days before the baseline visit or plan to use such investigational drug&#xD;
             (other than valbenazine) during the study&#xD;
&#xD;
          9. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline&#xD;
             visit&#xD;
&#xD;
         10. Have a history of severe hepatic impairment or history of protocol specified&#xD;
             hematologic abnormalities during the course of the NBI-98854-HD3005 study&#xD;
&#xD;
         11. Had a medically significant illness within 30 days before baseline, or any history of&#xD;
             neuroleptic malignant syndrome&#xD;
&#xD;
         12. Have a known hypersensitivity to any component of the formulation of valbenazine&#xD;
&#xD;
         13. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2&#xD;
             inhibitor use within 30 days of baseline&#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>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Neurocrine Medical Information Call Center</last_name>
    <phone>877-641-3461</phone>
    <email>medinfo@neurocrine.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Charlestown</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Neurocrine Clinical Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>MK2 1E1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://huntingtonstudygroup.org/current-clinical-trials/kinect-hd2/</url>
    <description>Study website</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</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>Huntington Disease</mesh_term>
    <mesh_term>Chorea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400331
org study id: NBI-98854-HD3006
nct id: NCT04400331
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of
      valbenazine, and to provide participants continued access to valbenazine for the treatment of
      chorea associated with Huntington disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to 156 weeks
measure: Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score
time frame: Up to 156 weeks
description: The TMC is part of the motor assessment of the UHDRS and measures chorea in 7 different body parts including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. A decrease in score indicates improvement in chorea.
arm group label: Valbenazine
arm group type: Experimental
description: Capsule, administered orally once daily.
intervention type: Drug
intervention name: Valbenazine
description: vesicular monoamine transporter 2 (VMAT2) inhibitor
arm group label: Valbenazine
other name: NBI-98854
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chief Medical Officer
role: Study Director
affiliation: Chief Medical Officer
last name: Neurocrine Medical Information Call Center
phone: 877-641-3461
email: medinfo@neurocrine.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Canada
country: United States
url: https://huntingtonstudygroup.org/current-clinical-trials/kinect-hd2/
description: Study website
responsible party type: Sponsor
mesh term: Huntington Disease
mesh term: Chorea
sharing ipd: No