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

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are treated with intravenous immune globulin or placebo. In the absence of a hypersensitivity reaction to a test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12 weeks.

Patients are followed at 3 months.

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