Autoimmune Encephalitis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
Interventions
DRUGImmunoglobulin G
IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.
Sponsors
Green Cross Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged more than 12 years.(adolescent or adult) 2. 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 3. Subjects or parent/legal representative willing to provide written informed consent
Exclusion criteria
1. Subject who has received Immunoglobulin therapy within 10 weeks prior to screening 2. Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin 3. Subject who has been diagnosed with IgA deficiency 4. Subject who has renal disorder (creatinine clearance \< 10 ml/min) or requires dialysis 5. Subject who has been diagnosed with hemolytic anemia or anemia from blood loss 6. Subject who has been diagnosed with immuonological competence or immunodeficiency 7. Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening) 8. 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) 9. Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.) 10. Females who are pregnant or breast feeding 11. Subject who is considered by investigator to ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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 |
Countries
South Korea
Outcome results
None listed