Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

September 23, 2021 updated by: Kon Chu, Seoul National University Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.

We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EPO
Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection
Drug: Erythropoietin
three times per a week 100IU / k
Other Names:
  • Epokine prefilled injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline modified Rankin Scale (mRS) at 12th week
Time Frame: 2nd week, 12th week
Favorable outcome is an improvement of mRS score.
2nd week, 12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effect
Time Frame: 2nd week, 4th week, 8th week, 12th week
Common terminology criteria for adverse events (CTCAE) 4.0
2nd week, 4th week, 8th week, 12th week
Quality of Life in Epilepsy Inventory (QOLIE) -31
Time Frame: 2nd week, 4th week, 8th week, 12th week
2nd week, 4th week, 8th week, 12th week
Mini-Mental State Examination (MMSE)
Time Frame: 2nd week, 4th week, 8th week, 12th week
2nd week, 4th week, 8th week, 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Kon Chu, Ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1607-120-777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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