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Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835507
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Seung Hyun Kim, Hanyang University Seoul Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: recombinant human erythropoietin(rhEPO) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
Actual Study Start Date : June 20, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
Inject Normal saline 100ml * 12 times (1month apart)
 Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months)
Experimental: Low dose group
Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
 Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months)
Experimental: High dose group
Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
 Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months)


Outcome Measures
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Primary Outcome Measures :
  1. changes of ALSFRS-R score [ Time Frame: Last visit [15th visit (15 months)] ]
    changes between score of ALSFRS-R at initial and study end point


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 25 to 80
  • upper motor neuron signs and lower motor neuron signs were identified in neurological examination.
  • Meet the revised El Escorial Criteria for clinically possible, probable-laboratory -supported, probable, definite ALS.
  • Disease duration < 3 years (Within 3 years from symptom onset)
  • ALSFRS-R score between 21 to 46
  • Patient who can visit an outpatient under the aid of his or her own walking or caregivers.
  • The person who have agreed in writing to participate in this clinical trial by themselves and the legal representative
  • FVC over 50% at screening

Exclusion Criteria:

  • Person who were not compatible with ALS
  • Patient with PLS or PMA
  • A group of patients who are concerned about the adverse effects of the drug administration (e.g. malignant hypertension,...)
  • ALSFRS-R score below 20 at screening
  • Ventilator user or Tracheostomy state patients at screening
  • Gastrostomy state at screening
  • FVC below 50% at screening or patient who cannot perform FVC test.
  • EKG abnormality, history of coronary stent , CABG at screening
  • Person who was given another clinical trial drug three months prior to screening.
  • History of seizure/ epilepsy
  • Abnormal renal function (serem creatinine > 2.0mg/dl)
  • Abnormal liver function(AST/ALT/bilirubin over 2 times the upper normal limit
  • Pregnant
  • Bleeding tendency at screening
  • Infectious disease at screening
  • Drug sensitivity
  • Person who injected erythropoietin 6 months prior to screening
  • Malignant tumor
  • Other neurological disease (stroke, parkinson's disease, dementia...)
  • Psychological disease
  • Hb more than 16g/dL
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835507


Contacts
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Contact: Jinseok Park, MD +82-2-2290-8367 jinseok.park0@gmail.com

Locations
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Korea, Republic of
Hanyang Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jinseok Park, MD    +82-2-2290-8367    jinseok.park0@gmail.com   
Sponsors and Collaborators
Hanyang University Seoul Hospital
More Information
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Publications of Results:

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Responsible Party: Seung Hyun Kim, MD, PhD, Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier: NCT03835507    
Other Study ID Numbers: HYNR-EPO
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Epoetin Alfa
Hematinics