Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00004744|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : September 9, 2008
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 or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: immune globulin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||76 participants|
|Study Start Date :||February 1993|
|Actual Primary Completion Date :||September 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004744
|Study Chair:||John H. Noseworthy||Mayo Clinic|