Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||February 1993|
|Primary Completion Date:||September 1998 (Final data collection date for primary outcome measure)|
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.
|Study Chair:||John H. Noseworthy||Mayo Clinic|