Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00004407|
Recruitment Status : Terminated
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathies||Drug: immune globulin||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||75 participants|
|Study Start Date :||February 1998|
|Study Completion Date :||March 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004407
|Study Chair:||Anthony J. Windebank||Mayo Clinic|