Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03004209

Enrollment

Registered

2016-12-28

Start date

2016-12-31

Completion date

2018-02-06

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalitis

Keywords

Erythropoietin, Autoimmune encephalitis

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.

Interventions

DRUGErythropoietin

three times per a week 100IU / k

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026