Status:
UNKNOWN
Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Hanyang University Seoul Hospital
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
25-80 years
Phase:
PHASE1
PHASE2
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 rep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03835507
Start Date
June 20 2016
End Date
December 1 2025
Last Update
February 8 2019
Active Locations (1)
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1
Hanyang Medical Center
Seoul, South Korea