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

Fecha de inicio: 1 de febrero de 1993

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