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This study will carry out to assess the efficacy of GB-0998 (intravenous immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to assess the safety of GB-0998.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB-0998 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB-0998 | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| days required for 1 grade improvement of FG | 1,2,3,4,6,8,12 weeks | |
| days required for 2 grade improvement of FG | 1,2,3,4,6,8,12 weeks | |
| changes in FG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoichi Nomura | Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Saitama Medical Center, Saitama Medical University | Kawagoe | Saitama | Japan |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 1,2,3,4,6,8,12 weeks |
| proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline | 4weeks |
| days required for 1 grade improvement of the AG | 1,2,3,4,6,8,12 weeks |
| days required for 2 grade improvement of the AG | 1,2,3,4,6,8,12 weeks |
| changes in AG | 1,2,3,4,6,8,12 weeks |
| changes in grip strength | 1,2,4,8,12 weeks |
| changes in manual muscle testing (MMT) | 1,2,4,8,12 weeks |
| changes in activity of daily living (ADL) | 1,2,4,8,12 weeks |
| changes in motor nerve conduction velocity | 4,12 weeks |
| changes in FG on rescue treatment | 1,2,3,4,6,8,12 weeks |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |