<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/NCT03254160</url>
  </required_header>
  <id_info>
    <org_study_id>DNS-3379-201</org_study_id>
    <nct_id>NCT03254160</nct_id>
  </id_info>
  <brief_title>DNS-3379 vs. Placebo in Stroke Rehabilitation</brief_title>
  <acronym>SPIRIT</acronym>
  <official_title>A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 42-Day Treatment Study to Evaluate the Effect of DNS-3379 on Upper Extremity Motor Function Following Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dart NeuroScience, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dart NeuroScience, LLC</source>
  <oversight_info>
    <has_dmc>No</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 randomized, double-blind, placebo-controlled parallel group outpatient 42-day&#xD;
      treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate&#xD;
      the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic&#xD;
      stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Administrative&#xD;
  </why_stopped>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D</measure>
    <time_frame>42-days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Type and incidence of treatment emergent adverse events</measure>
    <time_frame>84-days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Laboratory Assessments</measure>
    <time_frame>84-days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital signs and 12-lead ECG</measure>
    <time_frame>84-days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nine-Hole Peg Test</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia Suicide Severity Rating Scale</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-Minute Walk Test</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>84-days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>fMRI Imaging</measure>
    <time_frame>84-days</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>DNS-3379 (0.5mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DNS-3379 (2.5mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DNS-3379</intervention_name>
    <description>DNS-3379</description>
    <arm_group_label>DNS-3379 (0.5mg)</arm_group_label>
    <arm_group_label>DNS-3379 (2.5mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in&#xD;
             upper extremity deficit that warrants the need for rehabilitation therapy.&#xD;
&#xD;
          -  Medically stable subjects, with expected survival &gt; 12 months, who are able to be&#xD;
             randomized to study drug beginning between 1 and 52 weeks (i.e., 7 to 365 days)&#xD;
             post-stroke.&#xD;
&#xD;
          -  Mild to moderately severe upper extremity motor impairment.&#xD;
&#xD;
          -  mRS score of 1 to 4 from index stroke.&#xD;
&#xD;
          -  Mini Mental State Examination (MMSE) score of ≥ 22.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Residual motor deficit from any prior stroke&#xD;
&#xD;
          -  Hemorrhagic stroke. Ischemic stroke with limited hemorrhagic conversion (i.e.,&#xD;
             petechial hemorrhage or micro-hemorrhage) is acceptable.&#xD;
&#xD;
          -  Severe or total sensory loss&#xD;
&#xD;
          -  Moderate to severe aphasia and/or severe language deficits&#xD;
&#xD;
          -  Excessive spasticity in the affected elbow or change in oral spasticity treatment&#xD;
             drugs within 2 weeks before the Screening Visit&#xD;
&#xD;
          -  Prior botulinum toxin injection to any portion of the affected arm in the prior 3&#xD;
             months before the Screening Visit&#xD;
&#xD;
          -  Major and active neurological, psychiatric, or medical diagnosis that is not&#xD;
             adequately controlled and would likely reduce the safety of study participation or&#xD;
             impact the subject's ability to comply with study protocol procedures in the opinion&#xD;
             of the Investigator&#xD;
&#xD;
          -  Any suicidal ideation during the subject's lifetime at any time prior to randomization&#xD;
             including childhood (based on subject history), equivalent to type 2 on the&#xD;
             Columbia-Suicide Severity Rating Scale (C-SSRS)&#xD;
&#xD;
          -  Received an investigational pharmacotherapy therapy within the past 3 months&#xD;
&#xD;
          -  Heavy use of any tobacco-smoke emitting products (including but not limited to&#xD;
             cigarettes, pipes, and cigars) within 30 days of Baseline.&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>John Hunter Hospital</name>
      <address>
        <city>New Lambton Heights</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Birtinya</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Repatriation General Hospital</name>
      <address>
        <city>Daw Park</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyell McEwin</name>
      <address>
        <city>Elizabeth Vale</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Health</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albury/Wodonga Hospital</name>
      <address>
        <city>Wodonga</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hollywood Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Ischemic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Ischemia</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/NCT03254160
org study id: DNS-3379-201
nct id: NCT03254160
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day
      treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate
      the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic
      stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D
time frame: 42-days
measure: Type and incidence of treatment emergent adverse events
time frame: 84-days
measure: Safety Laboratory Assessments
time frame: 84-days
measure: Vital signs and 12-lead ECG
time frame: 84-days
measure: Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)
time frame: 84-days
measure: Nine-Hole Peg Test
time frame: 84-days
measure: Action Research Arm Test
time frame: 84-days
measure: Stroke Impact Scale
time frame: 84-days
measure: Modified Rankin Scale
time frame: 84-days
measure: Change in weight
time frame: 84-days
measure: Columbia Suicide Severity Rating Scale
time frame: 84-days
measure: Two-Minute Walk Test
time frame: 84-days
measure: EQ-5D-5L
time frame: 84-days
measure: fMRI Imaging
time frame: 84-days
arm group label: DNS-3379 (0.5mg)
arm group type: Experimental
arm group label: DNS-3379 (2.5mg)
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: DNS-3379
description: DNS-3379
arm group label: DNS-3379 (0.5mg)
arm group label: DNS-3379 (2.5mg)
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
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country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia
sharing ipd: No