Trials / Terminated
TerminatedNCT00004407
Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (planned)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | immune globulin |
Timeline
- Start date
- 1998-02-01
- Completion
- 2000-03-01
- First posted
- 1999-10-19
- Last updated
- 2015-03-25
Source: ClinicalTrials.gov record NCT00004407. Inclusion in this directory is not an endorsement.