Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Conditions
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Autoimmune Encephalitis

Intervention / Treatment
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* Drug: Erythropoietin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EPO<br>Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection | Drug: Erythropoietin<br>* three times per a week 100IU / k<br>* Other names: Epokine prefilled injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline modified Rankin Scale (mRS) at 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 | 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 |  | 2nd week, 4th week, 8th week, 12th week | 
| Mini-Mental State Examination (MMSE) |  | 2nd week, 4th week, 8th week, 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erythropoietin, Autoimmune encephalitis