Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
immune globulin
Autoimmune Diseases+11
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: February 1, 1993
Actual date on which the first participant was enrolled.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
This section provides details of the study plan, including how the study is designed and what the study is measuring.76 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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