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

Inclusion Criteria:

• Age between 25 to 80

• upper motor neuron signs and lower motor neuron signs were identified in neurologicalexamination.

• 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 orcaregivers.

• The person who have agreed in writing to participate in this clinical trial bythemselves 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 drugadministration (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