<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/NCT04479449</url>
  </required_header>
  <id_info>
    <org_study_id>SP-8203-2002</org_study_id>
    <nct_id>NCT04479449</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA</brief_title>
  <acronym>SP-8203-2002</acronym>
  <official_title>A Prospective, Randomized, Double-blind Phase 2b Clinical Trial to Investigate the Efficacy and Safety of SP-8203 in Patients With Acute Ischemic Stroke Requiring Recombinant Tissue Plasminogen Activator (rtPA) Standard of Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shin Poong Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shin Poong Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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 clinical trial is designed to evaluate the efficacy and safety of the combination&#xD;
      therapy of SP-8203 (Otaplimastat) and recombinant tissue Plasminogen Activator (rtPA)&#xD;
      standard of care. In this clinical trial, rtPA will be injected intravenously using an&#xD;
      infusion device. If reperfusion is not occur in spite of rtPA therapy, endovascular therapy&#xD;
      can be performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is designed to evaluate the efficacy and safety of the combination&#xD;
      therapy of SP-8203 and rtPA in patients with acute ischemic stroke receiving rtPA standard of&#xD;
      care.&#xD;
&#xD;
      As the standard procedure of rtPA therapy, rtPA will be injected intravenously using an&#xD;
      infusion device. When reperfusion is not achieved in spite of rtPA therapy, endovascular&#xD;
      therapy can be performed according to the judgment of a site investigator.&#xD;
&#xD;
      A total of 178 subjects will be enrolled in double-blind, randomized and parallel design with&#xD;
      89 subjects assigned to 80 mg/day SP-8203 group or placebo group, respectively.&#xD;
&#xD;
      If a subject, who is able to be enrolled, has neurologic deficit of ≥4 point on the National&#xD;
      Institute of Health Stroke Scale (NIHSS) score and give his/her consent to participate in the&#xD;
      trial, each treatment is administered after the investigational product is randomly assigned&#xD;
      by institution after sequential allocation. The randomization number of patients is the same&#xD;
      as the assigned number of the investigational product administered to the patients. The&#xD;
      subject will receive the Investigational products a total of 6 times, with 12 hours&#xD;
      intervals. Only for the patients who consent, blood sample will be taken after the sixth&#xD;
      administration of the Investigational product for pharmacokinetic and pharmacodynamics&#xD;
      analysis. For pharmacokinetic profile analysis, blood sample will be taken at 0~5, 30±5, and&#xD;
      120±5 minutes after the complete sixth administration of the investigational products. For&#xD;
      pharmacodynamic profile analysis, blood sample will be taken at between 24 to 48 hours after&#xD;
      the first administration, at 0 minute after the sixth administration and at 4th week visit.&#xD;
      The first blood sampling time is set to after 24 hours because of the patient's stability,&#xD;
      but it can be performed before the investigational product has been administered in&#xD;
      accordance with the judgment of the investigators.&#xD;
&#xD;
      The subject will have brain initial Magnetic Resonance Imaging (MRI) and Magnetic Resonance&#xD;
      Angiography (MRA) performed within 6 hours before and after the administration of&#xD;
      investigational product, and brain Computed Tomography (CT) will be performed at 24±3 hours&#xD;
      after completion of the first administration of investigational products.&#xD;
&#xD;
      Brain MRI and MRA will be followed-up on Day 5, and additionally the subject will make a&#xD;
      visit for close monitoring for his/her neurologic condition at 4th week and 12th week.&#xD;
      Thereafter, all the procedures of the clinical trial will be completed.&#xD;
&#xD;
      When unexpected serious adverse reaction occurs during the clinical trial, the safety of&#xD;
      subjects who participated in clinical trial and the clinical trial itself is objectively&#xD;
      validated through the convocation and evaluation by Data Safety Monitoring Board (DSMB).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">December 18, 2020</completion_date>
  <primary_completion_date type="Actual">October 19, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS)</measure>
    <time_frame>Change from 0 day at 28 days</time_frame>
    <description>The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS) until 28 day in subjects with acute ischemic stroke requiring rtPA (recombinant tissue Plasminogen Activator) standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan</measure>
    <time_frame>Day 1</time_frame>
    <description>Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan performed at 24±3 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria, after the administration of SP-8203 in conjunction with rtPA standard of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference in the distribution of modified Rankin Scale (mRS) scores</measure>
    <time_frame>Day 90</time_frame>
    <description>The difference in the distribution of modified Rankin Scale (mRS) scores in subjects with acute ischemic stroke requiring rtPA standard of care. The 0-6 point-scales are scored according to symptoms with 0 point indicating no disability; the higher score denotes ofr the more severe degree of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in the National Institute of Health Stroke Scale (NIHSS) scores</measure>
    <time_frame>Change from 0 day at 90 days</time_frame>
    <description>The change in the National Institute of Health Stroke Scale (NIHSS) scores until 90 day in subjects with acute ischemic stroke requiring rtPA standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in Barthel index</measure>
    <time_frame>Change from 0 day at 90 days</time_frame>
    <description>The change in Barthel index in subjects with acute ischemic stroke requiring rtPA standard of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The fold change of infarct growth classified by modified Treatment in Cerebral Ischemia (mTICI) grade within 5 days</measure>
    <time_frame>Day 5</time_frame>
    <description>MRI (DWI) imaging outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of occurrence and volume of intracranial hemorrhage classified by mTICI grade within 5 days</measure>
    <time_frame>Day 5</time_frame>
    <description>MRI (GRE) imaging outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of serious adverse events</measure>
    <time_frame>follow-up to 30 days after the last visit</time_frame>
    <description>The incidence of serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of death</measure>
    <time_frame>follow-up to 30 days after the last visit</time_frame>
    <description>The rate of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate of adverse events, and adverse drug reaction</measure>
    <time_frame>follow-up to 30 days after the last visit</time_frame>
    <description>The incidence rate of adverse events, and adverse drug reaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of symptomatic Intracranial Hemorrhage (sICH)</measure>
    <time_frame>within 5 days of administration</time_frame>
    <description>The incidence of sICH occurring within 5 days of administration according to the definition described on the protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of major systemic bleeding</measure>
    <time_frame>within 5 days of administration</time_frame>
    <description>The Incidence of major systemic bleeding according to the International Society of Thrombosis and Hemostasis (ISTH) definition</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>SP-8203</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SP-8203 80 mg (40 mg/dose twice a day for three days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group: twice a day for three days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SP-8203</intervention_name>
    <description>SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)</description>
    <arm_group_label>SP-8203</arm_group_label>
    <other_name>Otaplimastat (SP-8203)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be intravenously administered twice daily (intervals of 12 hours)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with neurologic deficit of ≥ 4 points by NIHSS score&#xD;
&#xD;
          -  Adults aged ≥19 years and ≤85 years. (Pre-stroke mRS must be 0 or 1; No significant&#xD;
             pre-stroke disability)&#xD;
&#xD;
          -  Subjects who can receive rtPA therapy within 4.5 hours after the onset of early&#xD;
             symptoms of acute ischemic stroke.&#xD;
&#xD;
          -  Subjects available for brain MRI (DWI, GRE/Susceptibility Weighted Imaging (SWI),&#xD;
             FLAIR, MRA) scanning&#xD;
&#xD;
          -  Subjects who consent to participate in this trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic allergic diseases or hypersensitivity to specific drugs.&#xD;
&#xD;
          -  Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.&#xD;
&#xD;
          -  Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation&#xD;
             within the last 6 months.&#xD;
&#xD;
          -  Patients showing the following abnormal ECG findings in stable condition at Emergency&#xD;
             Room:&#xD;
&#xD;
               -  The range of pulse rate - under 55/min or exceed 120/min&#xD;
&#xD;
               -  2nd or 3rd degree Atrioventricular (AV) block indicated in ECG&#xD;
&#xD;
               -  Congenital or acquired QT syndrome indicated in ECG&#xD;
&#xD;
               -  Pre-excitation syndrome indicated in ECG&#xD;
&#xD;
          -  Patients with severe heart failure of New York Heart Association (NYHA) Class III or&#xD;
             Class IV.&#xD;
&#xD;
          -  Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at&#xD;
             screening.&#xD;
&#xD;
          -  Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and&#xD;
             active tuberculosis etc.) who have being recently been treated more than 1 month at&#xD;
             screening.&#xD;
&#xD;
          -  Patients with decreased hemoglobin (Hb&lt; 10g/dL), decreased platelet count (PLT&lt;&#xD;
             100,000/mm3) or hematocrit of &lt;25% in complete blood count.&#xD;
&#xD;
          -  Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute&#xD;
             or chronic renal failure at screening.&#xD;
&#xD;
          -  Patients with a cancer in following conditions: diagnosed within 6 months before the&#xD;
             screening time, or any treatment for cancer within the previous 6 months, or with&#xD;
             recurrent/ metastatic cancer.&#xD;
&#xD;
          -  Pregnant and lactating women. However, women of childbearing age can participate in&#xD;
             the trial only when non-pregnancy is confirmed. Woman of childbearing age is defined&#xD;
             as woman who is not definitely menopause and did not receive a surgical contraception.&#xD;
&#xD;
          -  Patients who do not consent to use double barrier contraception during the trial&#xD;
             period.&#xD;
&#xD;
          -  Patients who have participated in other clinical trials of other drugs within the past&#xD;
             3 months. However, if they participated in observational studies and did not take&#xD;
             drugs, they can participate in this trial.&#xD;
&#xD;
          -  Patients who cannot participate in the trial according to the judgment of&#xD;
             investigators.&#xD;
&#xD;
          -  Those who cannot be administered with rtPA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Sung Kim, MD, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dae-IL Chang, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyunghee University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kyung Mi Oh, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jong-Ho Park, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Myongji Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kyung Bok Lee, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soonchunhyang University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sang Min Sung, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eung-Gyu Kim, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hee-Joon Bae, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jee-Hyun Kwon, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jae Gwan Cha, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dong-A University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Man Seok Park, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jong Moo Park, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nowon Eulji Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yang Ha Hwang, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SP-8203 (Otaplimastat)</keyword>
  <keyword>rtPA (recombinant tissue Plasminogen Activator)</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>Otaplimastat</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/NCT04479449
org study id: SP-8203-2002
nct id: NCT04479449
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This clinical trial is designed to evaluate the efficacy and safety of the combination
      therapy of SP-8203 (Otaplimastat) and recombinant tissue Plasminogen Activator (rtPA)
      standard of care. In this clinical trial, rtPA will be injected intravenously using an
      infusion device. If reperfusion is not occur in spite of rtPA therapy, endovascular therapy
      can be performed.
This clinical trial is designed to evaluate the efficacy and safety of the combination
      therapy of SP-8203 and rtPA in patients with acute ischemic stroke receiving rtPA standard of
      care.

      As the standard procedure of rtPA therapy, rtPA will be injected intravenously using an
      infusion device. When reperfusion is not achieved in spite of rtPA therapy, endovascular
      therapy can be performed according to the judgment of a site investigator.

      A total of 178 subjects will be enrolled in double-blind, randomized and parallel design with
      89 subjects assigned to 80 mg/day SP-8203 group or placebo group, respectively.

      If a subject, who is able to be enrolled, has neurologic deficit of ≥4 point on the National
      Institute of Health Stroke Scale (NIHSS) score and give his/her consent to participate in the
      trial, each treatment is administered after the investigational product is randomly assigned
      by institution after sequential allocation. The randomization number of patients is the same
      as the assigned number of the investigational product administered to the patients. The
      subject will receive the Investigational products a total of 6 times, with 12 hours
      intervals. Only for the patients who consent, blood sample will be taken after the sixth
      administration of the Investigational product for pharmacokinetic and pharmacodynamics
      analysis. For pharmacokinetic profile analysis, blood sample will be taken at 0~5, 30±5, and
      120±5 minutes after the complete sixth administration of the investigational products. For
      pharmacodynamic profile analysis, blood sample will be taken at between 24 to 48 hours after
      the first administration, at 0 minute after the sixth administration and at 4th week visit.
      The first blood sampling time is set to after 24 hours because of the patient's stability,
      but it can be performed before the investigational product has been administered in
      accordance with the judgment of the investigators.

      The subject will have brain initial Magnetic Resonance Imaging (MRI) and Magnetic Resonance
      Angiography (MRA) performed within 6 hours before and after the administration of
      investigational product, and brain Computed Tomography (CT) will be performed at 24±3 hours
      after completion of the first administration of investigational products.

      Brain MRI and MRA will be followed-up on Day 5, and additionally the subject will make a
      visit for close monitoring for his/her neurologic condition at 4th week and 12th week.
      Thereafter, all the procedures of the clinical trial will be completed.

      When unexpected serious adverse reaction occurs during the clinical trial, the safety of
      subjects who participated in clinical trial and the clinical trial itself is objectively
      validated through the convocation and evaluation by Data Safety Monitoring Board (DSMB).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS)
time frame: Change from 0 day at 28 days
description: The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS) until 28 day in subjects with acute ischemic stroke requiring rtPA (recombinant tissue Plasminogen Activator) standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.
measure: Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan
time frame: Day 1
description: Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan performed at 24±3 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria, after the administration of SP-8203 in conjunction with rtPA standard of care
measure: The difference in the distribution of modified Rankin Scale (mRS) scores
time frame: Day 90
description: The difference in the distribution of modified Rankin Scale (mRS) scores in subjects with acute ischemic stroke requiring rtPA standard of care. The 0-6 point-scales are scored according to symptoms with 0 point indicating no disability; the higher score denotes ofr the more severe degree of disability.
measure: The change in the National Institute of Health Stroke Scale (NIHSS) scores
time frame: Change from 0 day at 90 days
description: The change in the National Institute of Health Stroke Scale (NIHSS) scores until 90 day in subjects with acute ischemic stroke requiring rtPA standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.
measure: The change in Barthel index
time frame: Change from 0 day at 90 days
description: The change in Barthel index in subjects with acute ischemic stroke requiring rtPA standard of care
measure: The fold change of infarct growth classified by modified Treatment in Cerebral Ischemia (mTICI) grade within 5 days
time frame: Day 5
description: MRI (DWI) imaging outcomes
measure: The number of occurrence and volume of intracranial hemorrhage classified by mTICI grade within 5 days
time frame: Day 5
description: MRI (GRE) imaging outcomes
measure: The incidence of serious adverse events
time frame: follow-up to 30 days after the last visit
description: The incidence of serious adverse events
measure: The rate of death
time frame: follow-up to 30 days after the last visit
description: The rate of death due to any cause
measure: The incidence rate of adverse events, and adverse drug reaction
time frame: follow-up to 30 days after the last visit
description: The incidence rate of adverse events, and adverse drug reaction
measure: The incidence of symptomatic Intracranial Hemorrhage (sICH)
time frame: within 5 days of administration
description: The incidence of sICH occurring within 5 days of administration according to the definition described on the protocol
measure: The Incidence of major systemic bleeding
time frame: within 5 days of administration
description: The Incidence of major systemic bleeding according to the International Society of Thrombosis and Hemostasis (ISTH) definition
arm group label: SP-8203
arm group type: Experimental
description: SP-8203 80 mg (40 mg/dose twice a day for three days)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo group: twice a day for three days
intervention type: Drug
intervention name: SP-8203
description: SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)
arm group label: SP-8203
other name: Otaplimastat (SP-8203)
intervention type: Drug
intervention name: Placebo
description: Placebo will be intravenously administered twice daily (intervals of 12 hours)
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jong Sung Kim, MD, Phd
role: Study Chair
affiliation: Asan Medical Center
last name: Dae-IL Chang, MD, Phd
role: Principal Investigator
affiliation: Kyunghee University Medical Center
last name: Kyung Mi Oh, MD, Phd
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Jong-Ho Park, MD, Phd
role: Principal Investigator
affiliation: Myongji Hospital
last name: Kyung Bok Lee, MD, Phd
role: Principal Investigator
affiliation: Soonchunhyang University Hospital
last name: Sang Min Sung, MD, Phd
role: Principal Investigator
affiliation: Pusan National University Hospital
last name: Eung-Gyu Kim, MD, Phd
role: Principal Investigator
affiliation: Inje University
last name: Hee-Joon Bae, MD, Phd
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Jee-Hyun Kwon, MD, Phd
role: Principal Investigator
affiliation: Ulsan University Hospital
last name: Jae Gwan Cha, MD, Phd
role: Principal Investigator
affiliation: Dong-A University Hospital
last name: Man Seok Park, MD, Phd
role: Principal Investigator
affiliation: Chonnam National University Hospital
last name: Jong Moo Park, MD, Phd
role: Principal Investigator
affiliation: Nowon Eulji Medical Center
last name: Yang Ha Hwang, MD, Phd
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Otaplimastat