Clinical Trial: Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
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 Summary:
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.
Sponsor: Seoul National University Hospital
Current Primary Outcome: Change from Baseline modified Rankin Scale (mRS) at 12th week [ Time Frame: 2nd week, 12th week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse effect [ Time Frame: 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 [ Time Frame: 2nd week, 4th week, 8th week, 12th week ]
- Mini-Mental State Examination (MMSE) [ Time Frame: 2nd week, 4th week, 8th week, 12th week ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: December 21, 2016
Date Started: December 2016
Date Completion:
Last Updated: December 28, 2016
Last Verified: December 2016