Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intrav
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 28 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- immune globulin
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 1993
Main results due
Sept 1998