Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome

Inclusion criteria

• In principle, patients are able to receive the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms.
• Patients with predominant motor neuropathy and FG is grade 4 or grade 5 (if symptoms is progressive, patients with FG is grade 3 involve in this study).
• Patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset.

Exclusion criteria

• Patients who have the anamnesis of shock or hypersensitivity to GB-0998.
• Patients who have been diagnosed as hereditary fructose intolerance.
• Patients who have impaired peripheral neuropathy except Guillain-Barré syndrome.
• Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy.
• Patients who have received treatment of malignant tumors.
• Patients who were administered immunoglobulin within 8 weeks before informed consent.
• Patients who have been diagnosed IgA deficiency in their past history.
• Patients with severe renal disorder or decreased cardiac function.
• Patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases.
• Patients with high risk of thromboembolism.
• Pregnant, lactating, and probably pregnant patients.
• Patients who were administered other investigational drug within 12 weeks before consent.