NCT03835507

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

4.5 years

First QC Date

August 8, 2018

Last Update Submit

February 6, 2019

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • changes of ALSFRS-R score

    changes between score of ALSFRS-R at initial and study end point

    Last visit [15th visit (15 months)]

Study Arms (3)

Control group

PLACEBO COMPARATOR

Inject Normal saline 100ml \* 12 times (1month apart)

Drug: recombinant human erythropoietin(rhEPO)

Low dose group

EXPERIMENTAL

Inject 500IU/kg of EPO mixed with normal saline 100ml \* 12 times (1month apart)

Drug: recombinant human erythropoietin(rhEPO)

High dose group

EXPERIMENTAL

Inject 750IU/kg of EPO mixed with normal saline 100ml \* 12 times (1month apart)

Drug: recombinant human erythropoietin(rhEPO)

Interventions

recombinant human erythropoietin(rhEPO)DRUG

Injection of erythropoietin every months (total 12 months)

Control groupHigh dose groupLow dose group

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang Medical Center

Seoul, South Korea

RECRUITING

Related 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.

    PMID: 25324884RESULT

  • 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 2014 May 10.

    PMID: 24820540RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Jinseok Park, MD

CONTACT

+82-2-2290-8367jinseok.park0@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 8, 2018

First Posted

February 8, 2019

Study Start

June 20, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2025

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

KR(1)