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

Study Purpose:

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.

Study Status:



Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:

recombinant human erythropoietin(rhEPO)




Phase 1/Phase 2

Study Chair(s)/Principal Investigator(s):


Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Jinseok Park, MD / email hidden; JavaScript is required / +82-2-2290-8367

Study Sponsor:

Hanyang University Seoul Hospital

Estimated Enrollment:


Estimated Study Start Date:

06 / 20 / 2016

Estimated Study Completion Date:

12 / 01 / 2025

Posting Last Modified Date:

02 / 08 / 2019

Date Study Added to neals.org:

02 / 08 / 2019

Minimum Age:

25 Years

Maximum Age:

80 Years

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

Hanyang Medical Center | Recruiting

Jinseok Park, MD / +82-2-2290-8367 / email hidden; JavaScript is required

Korea, Republic of