Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Phase 4

Withdrawn

• Conditions: Autoimmune Encephalitis
• Interventions: Drug: Erythropoietin

• Registration Number: NCT03004209
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from Baseline modified Rankin Scale (mRS) at 12th week	2nd week, 12th week	Favorable outcome is an improvement of mRS score.

Secondary Outcome Measures

Name	Time	Method
Adverse effect	2nd week, 4th week, 8th week, 12th week	Common terminology criteria for adverse events (CTCAE) 4.0
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of