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| Sponsor: | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Collaborator: |
Mayo Clinic |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004744 |
Purpose
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 |
|---|---|---|
|
Multiple Sclerosis |
Drug: immune globulin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00004744 History of Changes |
| Other Study ID Numbers: | 199/11660, MAYOC-27992 |
| Study First Received: | February 24, 2000 |
| Last Updated: | September 8, 2008 |
| Health Authority: | United States: Federal Government |
|
multiple sclerosis neurologic and psychiatric disorders rare disease |
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Antibodies Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |