<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/NCT02973269</url>
  </required_header>
  <id_info>
    <org_study_id>RT002-CL008</org_study_id>
    <nct_id>NCT02973269</nct_id>
  </id_info>
  <brief_title>DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis</brief_title>
  <official_title>A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revance Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Revance Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of the study is to compare the safety and efficacy of a single&#xD;
      administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar&#xD;
      fasciitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    New trial with same indication initiated&#xD;
  </why_stopped>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in the visual analog pain score for the foot</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Plantar Fasciitis</condition>
  <arm_group>
    <arm_group_label>daxibotulinumtoxinA (DAXI) for injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAXI for injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Intramuscular injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>daxibotulinumtoxin type A</intervention_name>
    <description>Intramuscular injection</description>
    <arm_group_label>daxibotulinumtoxinA (DAXI) for injection</arm_group_label>
    <other_name>DAXI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intramuscular injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent, including authorization to release health information&#xD;
&#xD;
          -  Skeletally mature, male or female patients 18 to 65 years of age with diagnosis of&#xD;
             plantar fasciitis&#xD;
&#xD;
          -  Persistent heel pain for more than three months&#xD;
&#xD;
          -  Women of child bearing potential must have a negative urine pregnancy test (UPT) at&#xD;
             Screening Visit and must use an effective method of birth control during the course of&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery on the midfoot or hindfoot&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Systemic muscle weakness&#xD;
&#xD;
          -  Planning a pregnancy during the study&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within the last 30 days prior to first visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Wake Forest School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</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>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <disposition_first_submitted>November 11, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>November 11, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 15, 2019</disposition_first_posted>
  <last_update_submitted>November 11, 2019</last_update_submitted>
  <last_update_submitted_qc>November 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 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>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Plantar</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 2, 2023</submitted>
    <returned>June 26, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02973269
org study id: RT002-CL008
nct id: NCT02973269
lead sponsor: 
collaborator: 
has dmc: No
The specific aim of the study is to compare the safety and efficacy of a single
      administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar
      fasciitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
time frame: 16 weeks
measure: Reduction in the visual analog pain score for the foot
time frame: 16 weeks
arm group label: daxibotulinumtoxinA (DAXI) for injection
arm group type: Experimental
description: DAXI for injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Intramuscular injection
intervention type: Biological
intervention name: daxibotulinumtoxin type A
description: Intramuscular injection
arm group label: daxibotulinumtoxinA (DAXI) for injection
other name: DAXI
intervention type: Biological
intervention name: Placebo
description: Intramuscular injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
submitted: June 2, 2023
returned: June 26, 2023