Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004407
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Intravenous Immunoglobulin IVIg in Patients With Subacute Proximal Diabetic Neuropathy
Sponsor:
Mayo Clinic
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2001-01
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 the effect of intravenous immunoglobulin on recovery time of patients with proximal diabetic neuropathy
II Determine whether rate of response is dose dependent in these patients
II Determine whether rate of response is dose dependent in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to treatment with low dose intravenous immunoglobulin IVIg high dose IVIg or placebo
Patients must first complete baseline evaluation Patients receive IVIg or placebo on days 1 2 3 and 5 biweekly at weeks 2-4 weekly at weeks 5-8 and every other week at weeks 9-12
Patients are assessed at 6 12 36 52 and 104 weeks
Completion date provided represents the completion date of the grant per OOPD records
Patients must first complete baseline evaluation Patients receive IVIg or placebo on days 1 2 3 and 5 biweekly at weeks 2-4 weekly at weeks 5-8 and every other week at weeks 9-12
Patients are assessed at 6 12 36 52 and 104 weeks
Completion date provided represents the completion date of the grant per OOPD records
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-FDR001358 | None | None | None |
| MAYOC-91596 | None | None | None |