Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03835507 |
Recruitment Status :
Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Drug: recombinant human erythropoietin(rhEPO) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Other |
Official Title: | Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis |
Actual Study Start Date : | June 20, 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control group
Inject Normal saline 100ml * 12 times (1month apart)
|
Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months) |
Experimental: Low dose group
Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
|
Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months) |
Experimental: High dose group
Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
|
Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months) |
- changes of ALSFRS-R score [ Time Frame: Last visit [15th visit (15 months)] ]changes between score of ALSFRS-R at initial and study end point

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835507
Contact: Jinseok Park, MD | +82-2-2290-8367 | jinseok.park0@gmail.com |
Korea, Republic of | |
Hanyang Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Jinseok Park, MD +82-2-2290-8367 jinseok.park0@gmail.com |
Responsible Party: | Seung Hyun Kim, MD, PhD, Hanyang University Seoul Hospital |
ClinicalTrials.gov Identifier: | NCT03835507 |
Other Study ID Numbers: |
HYNR-EPO |
First Posted: | February 8, 2019 Key Record Dates |
Last Update Posted: | February 8, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases |
Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Epoetin Alfa Hematinics |