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Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Primary Purpose

Autoimmune Encephalitis

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erythropoietin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Encephalitis focused on measuring Erythropoietin, Autoimmune encephalitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EPO

Arm Description

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

Outcomes

Primary Outcome Measures

Change from Baseline modified Rankin Scale (mRS) at 12th week
Favorable outcome is an improvement of mRS score.

Secondary Outcome Measures

Adverse effect
Common terminology criteria for adverse events (CTCAE) 4.0
Quality of Life in Epilepsy Inventory (QOLIE) -31
Mini-Mental State Examination (MMSE)

Full Information

First Posted
December 21, 2016
Last Updated
September 23, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03004209
Brief Title
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Official Title
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Study Start Date
December 2016 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Encephalitis
Keywords
Erythropoietin, Autoimmune encephalitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPO
Arm Type
Other
Arm Description
Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Other Intervention Name(s)
Epokine prefilled injection
Intervention Description
three times per a week 100IU / k
Primary Outcome Measure Information:
Title
Change from Baseline modified Rankin Scale (mRS) at 12th week
Description
Favorable outcome is an improvement of mRS score.
Time Frame
2nd week, 12th week
Secondary Outcome Measure Information:
Title
Adverse effect
Description
Common terminology criteria for adverse events (CTCAE) 4.0
Time Frame
2nd week, 4th week, 8th week, 12th week
Title
Quality of Life in Epilepsy Inventory (QOLIE) -31
Time Frame
2nd week, 4th week, 8th week, 12th week
Title
Mini-Mental State Examination (MMSE)
Time Frame
2nd week, 4th week, 8th week, 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kon Chu, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

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