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Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Mayo Clinic |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004744 |
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 | Intervention | Phase |
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Multiple Sclerosis |
Drug: immune globulin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 76 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Other:
Study ID Numbers: | 199/11660, MAYOC-27992 |
Study First Received: | February 24, 2000 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00004744 History of Changes |
Health Authority: | United States: Federal Government |
multiple sclerosis neurologic and psychiatric disorders rare disease |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Rare Diseases Sclerosis Antibodies Multiple Sclerosis |
Mental Disorders Immunoglobulins, Intravenous Demyelinating Autoimmune Diseases, CNS Rho(D) Immune Globulin Autoimmune Diseases of the Nervous System Immunoglobulins |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Sclerosis Pharmacologic Actions |
Antibodies Multiple Sclerosis Pathologic Processes Immunoglobulins, Intravenous Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Immunoglobulins |