NCT03004209

Brief Summary

This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

December 21, 2016

Last Update Submit

September 23, 2021

Conditions

Autoimmune Encephalitis

Keywords

ErythropoietinAutoimmune encephalitis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline modified Rankin Scale (mRS) at 12th week

    Favorable outcome is an improvement of mRS score.

    2nd week, 12th week

Secondary Outcomes (3)

  • Adverse effect

    2nd week, 4th week, 8th week, 12th week

  • Quality of Life in Epilepsy Inventory (QOLIE) -31

    2nd week, 4th week, 8th week, 12th week

  • Mini-Mental State Examination (MMSE)

    2nd week, 4th week, 8th week, 12th week

Study Arms (1)

EPO

OTHER

Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection

Drug: Erythropoietin

Interventions

ErythropoietinDRUG

three times per a week 100IU / k

Also known as: Epokine prefilled injection
EPO

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed autoimmune encephalitis
  • Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)

You may not qualify if:

  • Hemoglobin \> 12g/dL
  • Hematochrit \>36%
  • Thrombocytosis \> 750K
  • AST or ALT \> 120
  • HIV (+)
  • Allergic reaction upon erythropoietin
  • Uncontrolled hypertension
  • mRS before the autoimmune encephalitis \> 3
  • Breast feeding or pregnancy
  • History of ischemic stroke or pulmonary thrombosis
  • Refuse to be enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Kon Chu, Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 28, 2016

Study Start

December 1, 2016

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)