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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835507
• Other study ID #: HYNR-EPO
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 20, 2016
• Est. completion date: December 2025

Study information

• Verified date: February 2019
• Source: Hanyang University Seoul Hospital
• Contact: Jinseok Park, MD
• Phone: +82-2-2290-8367
• Email: jinseok.park0[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 repetitive high-dose recombinant human erythropoietin (rhEPO) therapy in ALS patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months)

Locations

Country	Name	City	State
Korea, Republic of	Hanyang Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Kim HY, Moon C, Kim KS, Oh KW, Oh SI, Kim J, Kim SH. Recombinant human erythropoietin in amyotrophic lateral sclerosis: a pilot study of safety and feasibility. J Clin Neurol. 2014 Oct;10(4):342-7. doi: 10.3988/jcn.2014.10.4.342. Epub 2014 Oct 6. — View Citation

Noh MY, Cho KA, Kim H, Kim SM, Kim SH. Erythropoietin modulates the immune-inflammatory response of a SOD1(G93A) transgenic mouse model of amyotrophic lateral sclerosis (ALS). Neurosci Lett. 2014 Jun 27;574:53-8. doi: 10.1016/j.neulet.2014.05.001. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of ALSFRS-R score	changes between score of ALSFRS-R at initial and study end point	Last visit [15th visit (15 months)]