<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/NCT03821402</url>
  </required_header>
  <id_info>
    <org_study_id>1820203</org_study_id>
    <nct_id>NCT03821402</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity</brief_title>
  <acronym>JUNIPER</acronym>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revance Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Revance Therapeutics, Inc.</source>
  <oversight_info>
    <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 randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial&#xD;
      to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of&#xD;
      Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be&#xD;
      conducted in the U.S.A. , approximately 128 adult subjects from approximately 30 study&#xD;
      centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study&#xD;
      consists of a 21-day screening period, a treatment visit and follow-up visits.&#xD;
&#xD;
      The protocol was amended and the study was completed with fewer subjects than described in&#xD;
      the initial protocol due to impact of COVID-19 on enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomly assigned to DAXI for Injection high dose, DAXI for Injection medium&#xD;
      dose, DAXI for Injection low dose, or placebo group, respectively. Eligible subjects will&#xD;
      have ULS characterized by a primary aggregate posture&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 2020</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>
    <intervention_model_description>Eligible subjects will be randomized (1:1:1:1) to one of four treatment groups: Group 1: DAXI LOW DOSE (N=32); Group 2: DAXI MEDIUM DOSE (N=32); Group 3: DAXI HIGH DOSE (N=32); Group 4: Placebo (N=32).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blinded. The subject, Sponsor, and study site research personnel will be blinded to the identity of the subject's assigned treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline from suprahypertonic muscle group (SMG) score</measure>
    <time_frame>Week 6</time_frame>
    <description>Mean change from baseline in muscle tone measured with the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG) of the elbow, wrist, OR finger flexors at Week 6. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Physician Global Impression of Change (PGIC) score</measure>
    <time_frame>Week 6</time_frame>
    <description>Mean score on of the the Physician Global Impression of Change (PGIC) at Week 6. Score range: -4 (Markedly worse) to +4 (Markedly improved).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle tone improvement</measure>
    <time_frame>Weeks 6 and 12</time_frame>
    <description>Proportion of subjects who improve by a full point on the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Impression of Change (PGIC) improvement</measure>
    <time_frame>Weeks 6 and 12</time_frame>
    <description>Proportion of subjects with improvement (score ≥ 1) on the Physician Global Impression of Change (PGIC). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Assessment Scale (DAS) functional impairment</measure>
    <time_frame>Weeks 6 and 12</time_frame>
    <description>Change in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). Score range: 0 (No disability) to 3 (Severe disability - normal activities limited).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of effect</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>Duration of effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and immunogenicity assessment</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>Number of subjects with potential Botulinum Toxin type A distant spread of toxin adverse events, and number of subjects who develop neutralizing antibodies to Botulinum Toxin Type A will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Upper Limb Spasticity</condition>
  <arm_group>
    <arm_group_label>DAXI for injection dose LOW DOSE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LOW dose group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAXI for injection dose MEDIUM DOSE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MEDIUM dose group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAXI for injection Dose HIGH DOSE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIGH dose group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DAXI for injection dose LOW DOSE</intervention_name>
    <description>DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline</description>
    <arm_group_label>DAXI for injection dose LOW DOSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DAXI for injection dose MEDIUM DOSE</intervention_name>
    <description>DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.</description>
    <arm_group_label>DAXI for injection dose MEDIUM DOSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DAXI for injection Dose HIGH DOSE</intervention_name>
    <description>DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline</description>
    <arm_group_label>DAXI for injection Dose HIGH DOSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 75 years of age&#xD;
&#xD;
          -  Written informed consent including authorization to release health information&#xD;
&#xD;
          -  Focal upper limb spasticity (ULS) after a stroke (as defined by WHO criteria) or&#xD;
             traumatic brain injury (TBI), last stroke or TBI &gt; 24 weeks prior to Screening&#xD;
&#xD;
          -  ULS with the primary aggregate posture&#xD;
&#xD;
          -  Moderate to severe ULS with a MAS score ≥ 2 at the elbow, wrist, and finger flexors&#xD;
&#xD;
          -  Moderate to severe functional disability (Disability Assessment Score [DAS] score ≥2)&#xD;
             on the principal target of treatment&#xD;
&#xD;
          -  Has sufficient cognitive and communication ability to be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper limb spasticity attributable to an etiology other than stroke or TBI.&#xD;
&#xD;
          -  Bilateral upper limb paresis or quadriplegia.&#xD;
&#xD;
          -  Initiated in physiotherapy of the upper extremities ≤ 30 days prior to Screening or&#xD;
             planned to start physiotherapy of the upper extremities during the course of the&#xD;
             study.&#xD;
&#xD;
          -  Previous or planned treatment of the spastic upper limb with phenol, alcohol&#xD;
             injection, or surgery&#xD;
&#xD;
          -  Profound muscular atrophy or fixed contracture leading to marked limitation on range&#xD;
             of motion&#xD;
&#xD;
          -  Prior treatment with intrathecal baclofen&#xD;
&#xD;
          -  Any neuromuscular neurologic conditions (amyotrophic lateral sclerosis, Lambert-&#xD;
             Eaton, myasthenia gravis)&#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>Roman Rubio, MD</last_name>
    <role>Study Director</role>
    <affiliation>Revance Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rancho Research Institute at Rancho Los Amigos National Rehab Center</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Parkinsons and Movement Disorder Institute</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708-5153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network LLC</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC3 Research</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>Fairfield</city>
        <state>Connecticut</state>
        <zip>06824-5340</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waterbury Neurologists</name>
      <address>
        <city>Middlebury</city>
        <state>Connecticut</state>
        <zip>06762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ki Health Partners LLC DBA New England Institute for Clinical Research</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905-1206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar National Rehabilitation Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinsons Disease and Movement Disorders Center</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NW FL Clinical Research Group, LLC</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561-4458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinity Clinical Research</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinsons Disease Treatment Center of Southwest Florida</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33980-8421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shirley Ryan AbilityLab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2654</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas Institute of Research</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211-1358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rusk Rehabilitation Hospital</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065-4870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Rehabilitation</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University School of Medicine</name>
      <address>
        <city>Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MossRehab</name>
      <address>
        <city>Elkins Park</city>
        <state>Pennsylvania</state>
        <zip>19027-2220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh School of Medicine</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Institute of Neurology and Headache</name>
      <address>
        <city>Frisco</city>
        <state>Texas</state>
        <zip>75034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <disposition_first_submitted>December 22, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>December 22, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 29, 2020</disposition_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ULS</keyword>
  <keyword>JUNIPER</keyword>
  <keyword>DAXI for injection</keyword>
  <keyword>Botulinum toxin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 2, 2023</submitted>
    <returned>June 27, 2023</returned>
    <submitted>August 25, 2023</submitted>
  </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/NCT03821402
org study id: 1820203
nct id: NCT03821402
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial
      to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of
      Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be
      conducted in the U.S.A. , approximately 128 adult subjects from approximately 30 study
      centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study
      consists of a 21-day screening period, a treatment visit and follow-up visits.

      The protocol was amended and the study was completed with fewer subjects than described in
      the initial protocol due to impact of COVID-19 on enrollment.
Subjects will be randomly assigned to DAXI for Injection high dose, DAXI for Injection medium
      dose, DAXI for Injection low dose, or placebo group, respectively. Eligible subjects will
      have ULS characterized by a primary aggregate posture
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible subjects will be randomized (1:1:1:1) to one of four treatment groups: Group 1: DAXI LOW DOSE (N=32); Group 2: DAXI MEDIUM DOSE (N=32); Group 3: DAXI HIGH DOSE (N=32); Group 4: Placebo (N=32).
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blinded. The subject, Sponsor, and study site research personnel will be blinded to the identity of the subject's assigned treatment.
measure: Change from Baseline from suprahypertonic muscle group (SMG) score
time frame: Week 6
description: Mean change from baseline in muscle tone measured with the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG) of the elbow, wrist, OR finger flexors at Week 6. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension)
measure: Change from Baseline Physician Global Impression of Change (PGIC) score
time frame: Week 6
description: Mean score on of the the Physician Global Impression of Change (PGIC) at Week 6. Score range: -4 (Markedly worse) to +4 (Markedly improved).
measure: Muscle tone improvement
time frame: Weeks 6 and 12
description: Proportion of subjects who improve by a full point on the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)
measure: Physician Global Impression of Change (PGIC) improvement
time frame: Weeks 6 and 12
description: Proportion of subjects with improvement (score ≥ 1) on the Physician Global Impression of Change (PGIC). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)
measure: Disability Assessment Scale (DAS) functional impairment
time frame: Weeks 6 and 12
description: Change in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). Score range: 0 (No disability) to 3 (Severe disability - normal activities limited).
measure: Duration of effect
time frame: Up to 36 weeks
description: Duration of effect
measure: Safety and immunogenicity assessment
time frame: Up to 36 weeks
description: Number of subjects with potential Botulinum Toxin type A distant spread of toxin adverse events, and number of subjects who develop neutralizing antibodies to Botulinum Toxin Type A will be assessed.
arm group label: DAXI for injection dose LOW DOSE
arm group type: Experimental
description: LOW dose group
arm group label: DAXI for injection dose MEDIUM DOSE
arm group type: Experimental
description: MEDIUM dose group
arm group label: DAXI for injection Dose HIGH DOSE
arm group type: Experimental
description: HIGH dose group
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo group
intervention type: Biological
intervention name: DAXI for injection dose LOW DOSE
description: DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
arm group label: DAXI for injection dose LOW DOSE
intervention type: Biological
intervention name: DAXI for injection dose MEDIUM DOSE
description: DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
arm group label: DAXI for injection dose MEDIUM DOSE
intervention type: Biological
intervention name: DAXI for injection Dose HIGH DOSE
description: DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
arm group label: DAXI for injection Dose HIGH DOSE
intervention type: Other
intervention name: Placebo
description: Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Roman Rubio, MD
role: Study Director
affiliation: Revance Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Muscle Spasticity
sharing ipd: No
submitted: June 2, 2023
returned: June 27, 2023
submitted: August 25, 2023