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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2025
  • participants needed
    64
  • sponsor
    Hanyang University Seoul Hospital
Updated on 22 January 2021

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.

Details
Condition Myelopathy, Spinal Cord Disorders, Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment recombinant human erythropoietin(rhEPO)
Clinical Study IdentifierNCT03835507
SponsorHanyang University Seoul Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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