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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: immune globulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: immune globulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, neurologic and psychiatric disorders, rare disease