Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Clinically or laboratory-supported definite multiple sclerosis
• •Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive)
• •Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on Medical Research Clinic muscle power scale
• •Documented by Mayo Clinic Department of Neurology as neither progressing nor improving for 4 to 18 months prior to entry No clinical evidence of spontaneous or corticosteroid-induced improvement
• •Able to cooperate with isometric strength testing requirements
• •-Prior/Concurrent Therapy--
• •No concurrent experimental drug therapy
• •No concurrent intravenous immune globulin At least 3 months since immunosuppressive therapy, e.g., corticosteroids and corticotropin
• •At least 3 months since plasma exchange
• •-Patient Characteristics--
• •Hepatic: No coagulation defect, e.g., hyperviscosity syndrome
• •Renal: Creatinine no greater than 1.5 times normal
• •Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.: angina congestive heart failure transient ischemic attack stroke
• •Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia No known antibody deficiency syndrome, especially IgA deficiency
• •Other:
• •No condition interfering with neurologic exam, e.g.:
• •Major amputation
• •Deforming arthritis
• •Major psychiatric illness
• •Superimposed lower motor neuron deficit
• •No intellectual impairment precluding study participation
• •No pregnant or nursing women
• •Adequate contraception required of fertile patients