<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/NCT04427241</url>
  </required_header>
  <id_info>
    <org_study_id>kuhrm2020no1</org_study_id>
    <nct_id>NCT04427241</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness</brief_title>
  <official_title>Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ever Neuro Pharma GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness&#xD;
      caused by hemorrhagic stroke.&#xD;
&#xD;
      Participants: patients with prolonged disorders of consciousness due to severe traumatic&#xD;
      brain injury&#xD;
&#xD;
      Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or&#xD;
      100 ml normal saline, days 4-17, once/day, IV&#xD;
&#xD;
      Comparison: cerebrolysin group versus control group&#xD;
&#xD;
      Outcome: Coma Recovery Scale-revised, FDG-PET signal&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2023</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
  <phase>Phase 4</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>Coma Recovery Scale - revised</measure>
    <time_frame>2 days after randomization</time_frame>
    <description>Assessing the degree of disorders of consciousness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coma Recovery Scale - revised</measure>
    <time_frame>17 days after randomization</time_frame>
    <description>Assessing the degree of disorders of consciousness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positron Emitting Tomography</measure>
    <time_frame>2 days after randomization</time_frame>
    <description>Assessing the degree of brain neural network activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positron Emitting Tomography</measure>
    <time_frame>17 days after randomization</time_frame>
    <description>Assessing the degree of brain neural network activity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Disorder of Consciousness</condition>
  <condition>Hemorrhagic Stroke</condition>
  <arm_group>
    <arm_group_label>Cerebrolysin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 ml normal saline, days 4-17, once/day, IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cerebrolysin</intervention_name>
    <description>30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously</description>
    <arm_group_label>Cerebrolysin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>100 ml normal saline, days 4-17, once/day, IV</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Patients with hemorrhagic stroke confirmed by CT or MRI&#xD;
&#xD;
          2. Patients who have been in disorders of consciousness for more than 4 weeks after the&#xD;
             onset of hemorrhagic stroke&#xD;
&#xD;
          3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale&#xD;
             -revised: CRS-R assessment)&#xD;
&#xD;
          4. Age: 19 to 80 years of age&#xD;
&#xD;
          5. Patients who have voluntarily given written informed consent to participate in the&#xD;
             study by themselves or their legal representative.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Patients with confirmed epileptiform discharges on EEG&#xD;
&#xD;
          2. Patients with brain parenchymal defects&#xD;
&#xD;
          3. Patients with advanced liver, kidney, cardiac, or pulmonary disease.&#xD;
&#xD;
          4. Chronic treatment with medications that may affect consciousness, such as&#xD;
             antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.&#xD;
&#xD;
          5. History of serious illness within the last two years (cancer, hematologic, renal,&#xD;
             hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial&#xD;
             infarction, epilepsy), no evidence of secondary damage to major organs, and&#xD;
             well-controlled diabetes or hypertension.&#xD;
&#xD;
          6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).&#xD;
&#xD;
          7. Significant systemic disease or unstable medical condition that may compromise&#xD;
             compliance with the study protocol.&#xD;
&#xD;
          8. Administration of a contraindicated drug is essential for medical purposes.&#xD;
&#xD;
          9. Contraindications to the study drug (cerebrolysin).&#xD;
&#xD;
         10. Participation in another therapeutic study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Konkuk University Medical Center Research Coordinating Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Mi Soo Jang, Ph.D.</last_name>
      <phone>20305474</phone>
      <phone_ext>+822</phone_ext>
      <email>rcc@kuh.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654.</citation>
    <PMID>32057086</PMID>
  </reference>
  <reference>
    <citation>Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.</citation>
    <PMID>22375973</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
    <investigator_full_name>Jongmin Lee, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrolysin</mesh_term>
  </intervention_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/NCT04427241
org study id: kuhrm2020no1
nct id: NCT04427241
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness
      caused by hemorrhagic stroke.

      Participants: patients with prolonged disorders of consciousness due to severe traumatic
      brain injury

      Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or
      100 ml normal saline, days 4-17, once/day, IV

      Comparison: cerebrolysin group versus control group

      Outcome: Coma Recovery Scale-revised, FDG-PET signal
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Coma Recovery Scale - revised
time frame: 2 days after randomization
description: Assessing the degree of disorders of consciousness
measure: Coma Recovery Scale - revised
time frame: 17 days after randomization
description: Assessing the degree of disorders of consciousness
measure: Positron Emitting Tomography
time frame: 2 days after randomization
description: Assessing the degree of brain neural network activity
measure: Positron Emitting Tomography
time frame: 17 days after randomization
description: Assessing the degree of brain neural network activity
arm group label: Cerebrolysin
arm group type: Experimental
description: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
arm group label: Control
arm group type: Placebo Comparator
description: 100 ml normal saline, days 4-17, once/day, IV
intervention type: Drug
intervention name: Cerebrolysin
description: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
arm group label: Cerebrolysin
intervention type: Drug
intervention name: Control
description: 100 ml normal saline, days 4-17, once/day, IV
arm group label: Control
criteria: 
gender: All
minimum age: 19 Years
maximum age: 120 Years
healthy volunteers: No
facility: 
contact: 
country: Korea, Republic of
citation: Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654.
PMID: 32057086
citation: Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.
PMID: 22375973
responsible party type: Principal Investigator
investigator affiliation: Konkuk University Medical Center
investigator full name: Jongmin Lee, MD, PhD
investigator title: Professor
mesh term: Consciousness Disorders
mesh term: Hemorrhagic Stroke
mesh term: Cerebrolysin
sharing ipd: No