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The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Investigational product(IP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin G | Drug | IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse) | Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse) | Change and improvment of mRS score 14 days and 28 days after IP administration compared with baseline(before IP administration) | 28 days |
| Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better) |
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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:
Reasonable exclusion of alternative causes
Subjects or parent/legal representative willing to provide written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soon Tae Lee, MD, Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Change and improvment of Glasgow coma scale(GCS) 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration) |
| 28 days |
| Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse) | 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) | 28 days |
| Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse) | 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) | 28 days |
| Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse) | Change and improvment of CASE score 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration) | 28 days |
| The relationship | The relationship between neurological scale | 28 days |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |