<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/NCT01675115</url>
  </required_header>
  <id_info>
    <org_study_id>BNG-1-PIIIB</org_study_id>
    <nct_id>NCT01675115</nct_id>
  </id_info>
  <brief_title>Efficacy of BNG-1 to Treat Acute Ischemic Stroke</brief_title>
  <acronym>BNG-1</acronym>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Compare the Functional Outcome and Safety of Treatment With BNG-1 in Combination With Aspirin With That of Aspirin Alone in Ischemic Stroke Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the efficacy and safety of BNG-1 in patients&#xD;
      with ischemic stroke. The efficacy assessment will be based on the functional outcome while&#xD;
      the safety will be reviewed by the adverse events and laboratory examinations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint will be performed on the 12 weeks after study drug administered and will&#xD;
      compare the favorable rate between treatment with Aspirin alone and combination treatment&#xD;
      with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be&#xD;
      determined if all of the following occurs: alive, Modified Rankin Scale (MRS) &lt; 3, Barthel&#xD;
      Index (BI) &gt;= 60.&#xD;
&#xD;
      Secondary objectives are to compare the following:&#xD;
&#xD;
        1. Compare the favorable rate at one week after study drug administered and the end of&#xD;
           treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or&#xD;
           combination treatment with BNG-1 and Aspirin.&#xD;
&#xD;
        2. Compare the mean change in Barthel Index (BI), at each evaluation time-point of either&#xD;
           Aspirin alone or combination treatment with BNG-1 and Aspirin.&#xD;
&#xD;
        3. Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each&#xD;
           evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and&#xD;
           Aspirin.&#xD;
&#xD;
        4. Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin&#xD;
           alone or combination treatment with BNG-1 and Aspirin.&#xD;
&#xD;
        5. Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation&#xD;
           time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</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>Favorable rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Favorite rate: A composite of mortality (alive), modified Rankin Scale &lt; 3, AND Barthel Index (BI)&gt;=60</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Favorable rate</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel index</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health Stroke Scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extended Glasgow Outcome Scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>BNG-1 plus Aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Aspirin 100mg QD for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BNG-1</intervention_name>
    <description>BNG-1 3 grams TID for 4 weeks</description>
    <arm_group_label>BNG-1 plus Aspirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Aspirin 100 mg QD for 4 weeks</description>
    <arm_group_label>Aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both genders and ages 20 through 65 (subjects are at least 20 years old but not yet&#xD;
             66).&#xD;
&#xD;
          2. Clinical diagnosis of ischemic stroke, causing a measurable neurological deficit.&#xD;
&#xD;
          3. Onset of symptoms of ischemic stroke within 10 days of initiation of treatment with&#xD;
             the study drug.&#xD;
&#xD;
          4. Patients have a total National Institutes of Health Stroke Scale (NIHSS) between 8 and&#xD;
             22 inclusive by the time of randomization.&#xD;
&#xD;
          5. Patients have a total Barth Index (BI) less than 60 or Modified Rankin Scale (MRS) at&#xD;
             least 3 by the time of randomization.&#xD;
&#xD;
          6. No previous history of stroke or previous stroke with Modified Rankin Scale &lt; 1.&#xD;
&#xD;
          7. Patient must have a CT or MRI examination compatible with the clinical diagnosis of&#xD;
             acute ischemic stroke.&#xD;
&#xD;
          8. Signed informed consent from patient or legally authorized representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has only major symptoms that are rapidly improving by the time of&#xD;
             randomization.&#xD;
&#xD;
          2. History of stroke within the previous 3 months, exclude TIA.&#xD;
&#xD;
          3. Patient has a CT or MRI scan with evidence of a non-ischemic mechanism, subarachnoid&#xD;
             hemorrhage, primary intracerebral or intraventricular hemorrhage.&#xD;
&#xD;
          4. Patients with known or suspected prior intracranial haemorrhage or history of brain&#xD;
             injury or brain tumor.&#xD;
&#xD;
          5. Patient had documented history of any atrial fibrillation occurring 6 months before&#xD;
             randomization.&#xD;
&#xD;
          6. Hypertension, defined as systolic blood pressure &gt; 185 mmHg or diastolic blood&#xD;
             pressure &gt;110 mmHg or requiring aggressive (eg, intravenous antihypertensive)&#xD;
             treatment to reduce blood pressure to within these limits.&#xD;
&#xD;
          7. Recurrent peptic ulcer or gastrointestinal bleeding documented by radiographic or&#xD;
             endoscopic means within the past 3 months.&#xD;
&#xD;
          8. Pregnant or lactating women or women of childbearing potential who are not practicing&#xD;
             reliable birth control.&#xD;
&#xD;
          9. Platelet count less than 100,000 cells/ml.&#xD;
&#xD;
         10. Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above&#xD;
             the upper limit of normal for local laboratory.&#xD;
&#xD;
         11. International normalized ratio (INR) greater than or equal to 1.4.&#xD;
&#xD;
         12. Uncontrolled hyperglycemia (Sugar AC &gt; 200 mg/dl).&#xD;
&#xD;
         13. History of alcohol or drug abuse in the previous 3 months.&#xD;
&#xD;
         14. History of hypersensitivity or intolerance of study drug or aspirin.&#xD;
&#xD;
         15. Neurological (other than the presenting stroke) or psychiatric conditions that may&#xD;
             affect the patient's functional status and/or that may interfere with the patient's&#xD;
             assessment.&#xD;
&#xD;
         16. Previously in the BRAIN-Study or participation in a research protocol for&#xD;
             investigation of a pharmaceutical agent or innovative invasive procedure within the&#xD;
             past 30 days.&#xD;
&#xD;
         17. Any other known clinically significant medical disorder (e.g., a severe comorbid&#xD;
             disease or dementia, transient cerebral ischemia, lower gastrointestinal bleeding,&#xD;
             bleeding diathesis, hepatorenal diseases, cancer, and AIDS).&#xD;
&#xD;
         18. Patients who have received anticoagulant agents, antiplatelet agents (except Aspirin),&#xD;
             thrombolytics with 48-hour before randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsong-Hai Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief of Stroke Center, Linkou Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stroke center, Department of Neurology, Linkou Chang Gung Memorial Hospital</name>
      <address>
        <city>Kweishan</city>
        <state>Taoyuan</state>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>April 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Tsong-Hai Lee</investigator_full_name>
    <investigator_title>Chief of Stroke Center</investigator_title>
  </responsible_party>
  <keyword>Ischemic stroke</keyword>
  <keyword>Traditional Chinese Medication</keyword>
  <keyword>Aspirin</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>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_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/NCT01675115
org study id: BNG-1-PIIIB
nct id: NCT01675115
lead sponsor: 
has dmc: Yes
The objective of this study is to investigate the efficacy and safety of BNG-1 in patients
      with ischemic stroke. The efficacy assessment will be based on the functional outcome while
      the safety will be reviewed by the adverse events and laboratory examinations.
The primary endpoint will be performed on the 12 weeks after study drug administered and will
      compare the favorable rate between treatment with Aspirin alone and combination treatment
      with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be
      determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel
      Index (BI) >= 60.

      Secondary objectives are to compare the following:

        1. Compare the favorable rate at one week after study drug administered and the end of
           treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or
           combination treatment with BNG-1 and Aspirin.

        2. Compare the mean change in Barthel Index (BI), at each evaluation time-point of either
           Aspirin alone or combination treatment with BNG-1 and Aspirin.

        3. Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each
           evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and
           Aspirin.

        4. Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin
           alone or combination treatment with BNG-1 and Aspirin.

        5. Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation
           time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Favorable rate
time frame: 12 weeks
description: Favorite rate: A composite of mortality (alive), modified Rankin Scale < 3, AND Barthel Index (BI)>=60
measure: Favorable rate
time frame: 12 weeks
measure: Barthel index
time frame: 12 weeks
measure: Modified Rankin Scale
time frame: 12 weeks
measure: National Institute of Health Stroke Scale
time frame: 12 weeks
measure: Extended Glasgow Outcome Scale
time frame: 12 weeks
arm group label: BNG-1 plus Aspirin
arm group type: Active Comparator
description: BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks
arm group label: Aspirin
arm group type: Sham Comparator
description: Aspirin 100mg QD for 4 weeks
intervention type: Drug
intervention name: BNG-1
description: BNG-1 3 grams TID for 4 weeks
arm group label: BNG-1 plus Aspirin
intervention type: Drug
intervention name: Aspirin
description: Aspirin 100 mg QD for 4 weeks
arm group label: Aspirin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tsong-Hai Lee, MD, PhD
role: Principal Investigator
affiliation: Chief of Stroke Center, Linkou Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Tsong-Hai Lee
investigator title: Chief of Stroke Center
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Aspirin