<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/NCT03835507</url>
  </required_header>
  <id_info>
    <org_study_id>HYNR-EPO</org_study_id>
    <nct_id>NCT03835507</nct_id>
  </id_info>
  <brief_title>Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis</brief_title>
  <official_title>Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanyang University Seoul Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanyang University Seoul Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Erythropoietin is neuroprotective in animal models of neurodegenerative diseases including&#xD;
      amyotrophic lateral sclerosis (ALS). The aim of this study was to determine the safety and&#xD;
      feasibility of repetitive high-dose recombinant human erythropoietin (rhEPO) therapy in ALS&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 1/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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes of ALSFRS-R score</measure>
    <time_frame>Last visit [15th visit (15 months)]</time_frame>
    <description>changes between score of ALSFRS-R at initial and study end point</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inject Normal saline 100ml * 12 times (1month apart)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant human erythropoietin(rhEPO)</intervention_name>
    <description>Injection of erythropoietin every months (total 12 months)</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_label>Low dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 25 to 80&#xD;
&#xD;
          -  upper motor neuron signs and lower motor neuron signs were identified in neurological&#xD;
             examination.&#xD;
&#xD;
          -  Meet the revised El Escorial Criteria for clinically possible, probable-laboratory&#xD;
             -supported, probable, definite ALS.&#xD;
&#xD;
          -  Disease duration &lt; 3 years (Within 3 years from symptom onset)&#xD;
&#xD;
          -  ALSFRS-R score between 21 to 46&#xD;
&#xD;
          -  Patient who can visit an outpatient under the aid of his or her own walking or&#xD;
             caregivers.&#xD;
&#xD;
          -  The person who have agreed in writing to participate in this clinical trial by&#xD;
             themselves and the legal representative&#xD;
&#xD;
          -  FVC over 50% at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person who were not compatible with ALS&#xD;
&#xD;
          -  Patient with PLS or PMA&#xD;
&#xD;
          -  A group of patients who are concerned about the adverse effects of the drug&#xD;
             administration (e.g. malignant hypertension,...)&#xD;
&#xD;
          -  ALSFRS-R score below 20 at screening&#xD;
&#xD;
          -  Ventilator user or Tracheostomy state patients at screening&#xD;
&#xD;
          -  Gastrostomy state at screening&#xD;
&#xD;
          -  FVC below 50% at screening or patient who cannot perform FVC test.&#xD;
&#xD;
          -  EKG abnormality, history of coronary stent , CABG at screening&#xD;
&#xD;
          -  Person who was given another clinical trial drug three months prior to screening.&#xD;
&#xD;
          -  History of seizure/ epilepsy&#xD;
&#xD;
          -  Abnormal renal function (serem creatinine &gt; 2.0mg/dl)&#xD;
&#xD;
          -  Abnormal liver function(AST/ALT/bilirubin over 2 times the upper normal limit&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Bleeding tendency at screening&#xD;
&#xD;
          -  Infectious disease at screening&#xD;
&#xD;
          -  Drug sensitivity&#xD;
&#xD;
          -  Person who injected erythropoietin 6 months prior to screening&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Other neurological disease (stroke, parkinson's disease, dementia...)&#xD;
&#xD;
          -  Psychological disease&#xD;
&#xD;
          -  Hb more than 16g/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jinseok Park, MD</last_name>
    <phone>+82-2-2290-8367</phone>
    <email>jinseok.park0@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinseok Park, MD</last_name>
      <phone>+82-2-2290-8367</phone>
      <email>jinseok.park0@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Kim HY, Moon C, Kim KS, Oh KW, Oh SI, Kim J, Kim SH. Recombinant human erythropoietin in amyotrophic lateral sclerosis: a pilot study of safety and feasibility. J Clin Neurol. 2014 Oct;10(4):342-7. doi: 10.3988/jcn.2014.10.4.342. Epub 2014 Oct 6.</citation>
    <PMID>25324884</PMID>
  </results_reference>
  <results_reference>
    <citation>Noh MY, Cho KA, Kim H, Kim SM, Kim SH. Erythropoietin modulates the immune-inflammatory response of a SOD1(G93A) transgenic mouse model of amyotrophic lateral sclerosis (ALS). Neurosci Lett. 2014 Jun 27;574:53-8. doi: 10.1016/j.neulet.2014.05.001. Epub 2014 May 10.</citation>
    <PMID>24820540</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 8, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University Seoul Hospital</investigator_affiliation>
    <investigator_full_name>Seung Hyun Kim</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03835507
org study id: HYNR-EPO
nct id: NCT03835507
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Erythropoietin is neuroprotective in animal models of neurodegenerative diseases including
      amyotrophic lateral sclerosis (ALS). The aim of this study was to determine the safety and
      feasibility of repetitive high-dose recombinant human erythropoietin (rhEPO) therapy in ALS
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: changes of ALSFRS-R score
time frame: Last visit [15th visit (15 months)]
description: changes between score of ALSFRS-R at initial and study end point
arm group label: Control group
arm group type: Placebo Comparator
description: Inject Normal saline 100ml * 12 times (1month apart)
arm group label: Low dose group
arm group type: Experimental
description: Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
arm group label: High dose group
arm group type: Experimental
description: Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
intervention type: Drug
intervention name: recombinant human erythropoietin(rhEPO)
description: Injection of erythropoietin every months (total 12 months)
arm group label: Control group
arm group label: High dose group
arm group label: Low dose group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jinseok Park, MD
phone: +82-2-2290-8367
email: jinseok.park0@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Kim HY, Moon C, Kim KS, Oh KW, Oh SI, Kim J, Kim SH. Recombinant human erythropoietin in amyotrophic lateral sclerosis: a pilot study of safety and feasibility. J Clin Neurol. 2014 Oct;10(4):342-7. doi: 10.3988/jcn.2014.10.4.342. Epub 2014 Oct 6.
PMID: 25324884
citation: Noh MY, Cho KA, Kim H, Kim SM, Kim SH. Erythropoietin modulates the immune-inflammatory response of a SOD1(G93A) transgenic mouse model of amyotrophic lateral sclerosis (ALS). Neurosci Lett. 2014 Jun 27;574:53-8. doi: 10.1016/j.neulet.2014.05.001. Epub 2014 May 10.
PMID: 24820540
responsible party type: Principal Investigator
investigator affiliation: Hanyang University Seoul Hospital
investigator full name: Seung Hyun Kim
investigator title: MD, PhD
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis
mesh term: Epoetin Alfa
sharing ipd: Undecided