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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Mayo Clinic |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004407 |
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 | Intervention |
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Diabetic Neuropathies |
Drug: immune globulin |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 75 |
Study Start Date: | February 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/13294, MAYOC-91596, MAYOC-FDR001358 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004407 History of Changes |
Health Authority: | United States: Federal Government |
diabetic amyotrophy diabetic lumbosacral radiculoplexus neuropathy diabetic neuropathy |
diabetic proximal neuropathy neurologic and psychiatric disorders rare disease |
Immunologic Factors Diabetic Neuropathies Rare Diseases Diabetes Mellitus Endocrine System Diseases Antibodies Neuromuscular Diseases Mental Disorders |
Immunoglobulins, Intravenous Peripheral Nervous System Diseases Rho(D) Immune Globulin Endocrinopathy Muscular Atrophy Diabetes Complications Immunoglobulins |
Diabetic Neuropathies Immunologic Factors Nervous System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Pharmacologic Actions |
Antibodies Neuromuscular Diseases Immunoglobulins, Intravenous Peripheral Nervous System Diseases Diabetes Complications Immunoglobulins |