<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/NCT02258880</url>
  </required_header>
  <id_info>
    <org_study_id>ASBI 802</org_study_id>
    <nct_id>NCT02258880</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke</brief_title>
  <official_title>A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SUN13837 Administered 28 Doses (27/28 Days) to Adult Subjects With an Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to&#xD;
      determine whether SUN13837 improves the physical performance, relative to placebo, following&#xD;
      an acute stroke in adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study was stopped for business/administrative reasons and not for patient safety concerns&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</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>Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)</measure>
    <time_frame>84 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of responders as measured by the PPAS</measure>
    <time_frame>84 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in PPAS Patient Reported Outcome Subscale</measure>
    <time_frame>84 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)</measure>
    <time_frame>84 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Gait Speed</measure>
    <time_frame>84 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of responders as measured by the Modified Rankin Scale (mRS)</measure>
    <time_frame>84 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety/Tolerability - Number of Participants with Adverse Events</measure>
    <time_frame>84 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>SUN13837</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: SUN13837 daily for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: Matching Placebo daily for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUN13837</intervention_name>
    <arm_group_label>SUN13837</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>
        Each subject must meet all of the following criteria to participate in the study:&#xD;
&#xD;
          1. Male or female subjects between 18 and 85 years, inclusive&#xD;
&#xD;
          2. Subjects with no prior history of stroke (unless the stroke was not associated with a&#xD;
             motor deficit)&#xD;
&#xD;
          3. Subjects must score at least 16 points on the standard MMSE during baseline&#xD;
             assessments&#xD;
&#xD;
          4. Subjects must have a total score between 7 and 30, inclusive, out of 35 on the&#xD;
             S-STREAM administered between 24 and 48 hours after the onset of acute stroke&#xD;
&#xD;
          5. Subjects must have an estimated pre-stroke mRS of 0 or 1&#xD;
&#xD;
          6. Male subjects agree to be heterosexually abstinent or use appropriate contraception&#xD;
&#xD;
          7. Female subjects must have undergone menopause or, if premenopausal, must have a&#xD;
             negative pregnancy test at baseline. Female subjects of childbearing potential agree&#xD;
             to be sexually abstinent or must be willing to utilize adequate contraception&#xD;
&#xD;
          8. Subjects must be willing to provide verbal/nonverbal informed consent indicating&#xD;
             voluntary consent to participate in the study (if a subject is unable to provide&#xD;
             informed consent, but able to comply with other study procedures, the subject's LAR&#xD;
             may provide consent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who meet any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Prior exposure to SUN13837&#xD;
&#xD;
          2. History of severe allergic reaction, whether explained or not, requiring a visit to&#xD;
             the ER and/or medical intervention with epinephrine&#xD;
&#xD;
          3. Development of hemodynamic instability following the acute stroke&#xD;
&#xD;
          4. History of dementia, advanced Parkinson's disease, other significant movement&#xD;
             disorders, or other clinically significant diseases which would jeopardize the safety&#xD;
             of the subject or impact the validity of the study results&#xD;
&#xD;
          5. Presence of significant global or receptive aphasia&#xD;
&#xD;
          6. Presence of clinically significant abnormal laboratory values at the time of&#xD;
             presentation in the ER&#xD;
&#xD;
          7. History of malabsorption or any gastrointestinal abnormality that could impair oral&#xD;
             absorption&#xD;
&#xD;
          8. Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination&#xD;
             or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes&#xD;
             mellitus&#xD;
&#xD;
          9. Unable, as determined by the investigator, or unwilling to discontinue use of potent&#xD;
             cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or&#xD;
             potent P glycoprotein (P gp) inhibitors&#xD;
&#xD;
         10. Current participation in another clinical study involving administration of an&#xD;
             investigational product or history of such participation within 30 days of acute&#xD;
             stroke onset&#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>Ger Rikken, MD</last_name>
    <role>Study Director</role>
    <affiliation>Asubio Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36693</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Encinita</city>
        <state>California</state>
        <zip>92024</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>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08818</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paoli</city>
        <state>Pennsylvania</state>
        <zip>19301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</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>Mechanicsville</city>
        <state>Virginia</state>
        <zip>23116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St-Jerome</city>
        <state>Quebec</state>
        <zip>J7Z 5T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <zip>3339419</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Naharyia</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ramat Gan</city>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bloemfontein</city>
        <state>Free State</state>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alberton</city>
        <state>Gauteng</state>
        <zip>1449</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krugersdorp</city>
        <state>Gauteng</state>
        <zip>1739</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellville</city>
        <state>Western Cape</state>
        <zip>7350</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Somerset West</city>
        <state>Western Cape</state>
        <zip>7130</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Worcester</city>
        <state>Western Cape</state>
        <zip>6850</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Israel</country>
    <country>South Africa</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Stroke</keyword>
  <keyword>Outcome Measures</keyword>
  <keyword>Physical Performance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT02258880
org study id: ASBI 802
nct id: NCT02258880
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to
      determine whether SUN13837 improves the physical performance, relative to placebo, following
      an acute stroke in adult subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
time frame: 84 days
measure: The proportion of responders as measured by the PPAS
time frame: 84 days
measure: Mean change from baseline in PPAS Patient Reported Outcome Subscale
time frame: 84 days
measure: Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)
time frame: 84 days
measure: Mean change from baseline in Gait Speed
time frame: 84 days
measure: Proportion of responders as measured by the Modified Rankin Scale (mRS)
time frame: 84 days
measure: Safety/Tolerability - Number of Participants with Adverse Events
time frame: 84 days
arm group label: SUN13837
arm group type: Experimental
description: Drug: SUN13837 daily for 28 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo: Matching Placebo daily for 28 days
intervention type: Drug
intervention name: SUN13837
arm group label: SUN13837
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: Ger Rikken, MD
role: Study Director
affiliation: Asubio Pharmaceuticals, Inc.
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country: Canada
country: Israel
country: South Africa
country: United States
responsible party type: Sponsor
mesh term: Stroke