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

This is an interventional other trial for Amyotrophic Lateral Sclerosis Read More

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