Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004744
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
II Determine the time to recovery following IVIG
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
Patients are followed at 3 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MAYOC-27992 | None | None | None |