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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis.

II. Determine the time to recovery following IVIG.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Collaborator: Mayo Clinic
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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