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:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
recombinant human erythropoietin(rhEPO)
Placebo:
Yes
Phase:
Phase 1/Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Jinseok Park, MD / email hidden; JavaScript is required / +82-2-2290-8367
Study Sponsor:
Hanyang University Seoul Hospital
Estimated Enrollment:
64
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
Seoul
Korea, Republic of