Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

Recruitment & Eligibility

Inclusion Criteria

Male or female, aged more than 12 years.(adolescent or adult)
Subject who all three of the following diagnosis criteria for possible autoimmune encephalitis have been met.
- Subacute onset (rapid progression of less than 3 months) of working memory deficits(short-term memory loss), altered mental status, or psychiatric symptoms.
- At least one of the following:
  - New focal CNS findings
  - Seizure not explained by a previously known seizure disorder
  - CSF pleocytosis (WBC count ≥ 5/mm2)
  - MRI features suggestive of encephalitis
- Reasonable exclusion of alternative causes
Subjects or parent/legal representative willing to provide written informed consent

Exclusion Criteria

Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
Subject who has been diagnosed with IgA deficiency
Subject who has renal disorder (creatinine clearance < 10 ml/min) or requires dialysis
Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
Subject who has been diagnosed with immuonological competence or immunodeficiency
Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
Subject who has low heart condition (Congestive heart failure >NYHA functional class Ⅱ: unstable coronary artery disease or myocardiac infarction within 3 months prior to screening)
Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
Females who are pregnant or breast feeding
Subject who is considered by investigator to ineligible for the study.

Study & Design

Arm && Interventions

Group	Intervention	Description
Experimental	Immunoglobulin G	Investigational product(IP)

Primary Outcome Measures

Name	Time	Method
Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)	28 days	Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration)

Secondary Outcome Measures

Name	Time	Method
Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)	28 days	Change and improvment of mRS score 14 days and 28 days after IP administration compared with baseline(before IP administration)
Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)	28 days	Change and improvment of Clinical Global Impression Scale-Severity 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)
Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)	28 days	Change and improvment of Clinical Global Impression Scale-Improvement 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)
Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)	28 days	Change and improvment of CASE score 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)
The relationship	28 days	The relationship between neurological scale
Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)	28 days	Change and improvment of Glasgow coma scale(GCS) 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Recruitment & Eligibility