<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/NCT02242084</url>
  </required_header>
  <id_info>
    <org_study_id>AK 23 - 14</org_study_id>
    <nct_id>NCT02242084</nct_id>
  </id_info>
  <brief_title>Thrombolysis in Ischemic Spinal Cord Stroke</brief_title>
  <official_title>Thrombolysis in Ischemic Spinal Cord Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic&#xD;
      events in the central nervous system (CNS). In most cases the consequences are catastrophic,&#xD;
      with a high rate of severe functional disability and mortality rate up to 30%.&#xD;
&#xD;
      Ischemic stroke of the spinal cord can arise from:&#xD;
&#xD;
        1. Dissection of the aorta.&#xD;
&#xD;
        2. Aneurism in the aorta.&#xD;
&#xD;
        3. Atherosclerotic disease of the aorta or vertebral arteries.&#xD;
&#xD;
        4. Spinal surgeries.&#xD;
&#xD;
        5. Spinal AVM.&#xD;
&#xD;
        6. Embolism from cardiac origin.&#xD;
&#xD;
        7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in&#xD;
           hours until the patient becomes paralyzed in two or in all four limbs. In most cases the&#xD;
           damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor&#xD;
           weakness accompanied by disturbance of temperature and superficial sensation, urinary&#xD;
           retention or bowel disorder, with preserved position and vibration sense.&#xD;
&#xD;
      The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis&#xD;
      of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS).&#xD;
      Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the&#xD;
      spinal cord is necessary upon arrival in the emergency department.&#xD;
&#xD;
      One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and&#xD;
      validated in numerous studies for ischemic events in the brain, until today no validated&#xD;
      study in ischemic spinal stroke using thrombolysis has been completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">March 26, 2019</completion_date>
  <primary_completion_date type="Actual">March 26, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Ranking Scale (mRS)</measure>
    <time_frame>3 month post thrombolysis</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Motor Weakness in Two or Four Limbs</condition>
  <condition>Damage in the Anterior Spinal Artery (ASA)</condition>
  <condition>Temperature and Superficial Sensation</condition>
  <condition>Urinary Retention or Bowel Disorder</condition>
  <arm_group>
    <arm_group_label>Alteplase treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subject who enter the trial will receive treatment with Alteplase along with questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenuse Alteplase</intervention_name>
    <arm_group_label>Alteplase treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with vascular risk factors&#xD;
&#xD;
          2. Patients with sudden weakness of the lower or upper limbs together with bowel&#xD;
             disorder.&#xD;
&#xD;
          3. Window treatment - not over 6 hours since the start of the event till the start of the&#xD;
             treatment.&#xD;
&#xD;
          4. Patient without dissection of the aorta in the abdomen.&#xD;
&#xD;
          5. Patient without contraindication to IVtPA.&#xD;
&#xD;
          6. Patient with no etiology found after clarification.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with&#xD;
        contraindication IVtPA.&#xD;
&#xD;
        -&#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>Israel Steiner, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tiqva</city>
        <state>Hamerkaz</state>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>israel Steiner</investigator_full_name>
    <investigator_title>Head of Neurology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Plasminogen Activator</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/NCT02242084
org study id: AK 23 - 14
nct id: NCT02242084
lead sponsor: 
has dmc: No
Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic
      events in the central nervous system (CNS). In most cases the consequences are catastrophic,
      with a high rate of severe functional disability and mortality rate up to 30%.

      Ischemic stroke of the spinal cord can arise from:

        1. Dissection of the aorta.

        2. Aneurism in the aorta.

        3. Atherosclerotic disease of the aorta or vertebral arteries.

        4. Spinal surgeries.

        5. Spinal AVM.

        6. Embolism from cardiac origin.

        7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in
           hours until the patient becomes paralyzed in two or in all four limbs. In most cases the
           damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor
           weakness accompanied by disturbance of temperature and superficial sensation, urinary
           retention or bowel disorder, with preserved position and vibration sense.

      The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis
      of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS).
      Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the
      spinal cord is necessary upon arrival in the emergency department.

      One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and
      validated in numerous studies for ischemic events in the brain, until today no validated
      study in ischemic spinal stroke using thrombolysis has been completed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Modified Ranking Scale (mRS)
time frame: 3 month post thrombolysis
arm group label: Alteplase treatment
arm group type: Experimental
description: All subject who enter the trial will receive treatment with Alteplase along with questionnaire.
intervention type: Drug
intervention name: Intravenuse Alteplase
arm group label: Alteplase treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Israel Steiner, Professor
role: Principal Investigator
affiliation: Rabin Medical Center
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: israel Steiner
investigator title: Head of Neurology Department
mesh term: Intestinal Diseases
mesh term: Urinary Retention
mesh term: Tissue Plasminogen Activator