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.

Condition	Treatment or Intervention	Phase
Multiple Sclerosis	Drug: immune globulin	Phase III

Further Study Details: 

Expected Total Enrollment:  76

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

John H. Noseworthy,  Study Chair,  Mayo Clinic   

Study ID Numbers:  199/11660; MAYOC-27992
Record last reviewed:  January 1998
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004744
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08