Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses

Exclusion Criteria

• •A woman who is pregnant, breastfeeding, or planning pregnancy.
• •If the patient is enrolled in any other experimental trial or on other experimental therapy.
• •If the patient has a known IgA deficiency with IgA-antibodies.
• •Any medical condition or clinically significant laboratory abnormality that in the Investigator's judgment may affect the patient's ability to safely complete the study.
• •Acute attack:
• •The occurrence of new or worsening neurological symptoms consistent with optic neuritis, transverse myelitis, or a brain lesion that develop acutely (i.e., patients must present within 7 days of symptom onset).
• •The symptoms must persist for at least 48 hours, are not attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to concomitant medications).
• •The symptoms must be accompanied by sensory, motor or visual acuity objective deficits, which must be verified by the examining physician.
• •A single episode of a paroxysmal symptom (e.g., tonic spasm) is not a relapse; however, the new onset of multiple occurrences of a paroxysmal symptom over at least 48 hours can be a relapse if accompanied by a new, corresponding objective deficit.
• •Sensory symptoms with no change on clinical examination, fatigue, mood change, or bladder or bowel urgency or incontinence will not be sufficient to establish a relapse.