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| Descriptive Information Fields | |||||
| Brief Title † | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis | ||||
| Official Title † | |||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Multiple Sclerosis | ||||
| Intervention † | Drug: immune globulin | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 76 | ||||
| Start Date † | February 1993 | ||||
| Completion Date | |||||
| Eligibility Criteria † | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Other:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004744 | ||||
| Organization ID | 199/11660 | ||||
| Secondary IDs †† | MAYOC-27992 | ||||
| Study Sponsor † | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Collaborators †† | Mayo Clinic | ||||
| Investigators † |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | January 1998 | ||||
| First Received Date † | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||