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Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy

Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Neuropathies

Intervention: immune globulin (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: FDA Office of Orphan Products Development

Official(s) and/or principal investigator(s):
Anthony J. Windebank, Study Chair, Affiliation: Mayo Clinic

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.

Clinical Details

Study design: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

PROTOCOL ENTRY CRITERIA:

- -Disease Characteristics--

- Diagnostically proven non-insulin dependent diabetes mellitus as defined by the

following criteria: Presence of classic symptoms, such as polyuria, polydipsia, ketonuria, and rapid weight loss, together with plasma glucose elevations Elevated fasting glucose concentration on more than one occasion

- Diagnostically proven proximal diabetic neuropathy with any of the following symptoms:

Severe thigh, hip, or leg pain Greater than 20% weight loss Progressive proximal weakness in the painful leg Weakness in the contralateral lower limb Thoracic or cervical root distribution Symmetric distal polyneuropathy or autonomic neuropathy may be mild or absent

- -Prior/Concurrent Therapy--

- At least 6 months since prior immunosuppression or plasma exchange

- No history of prior renal transplant

- -Patient Characteristics--

- Age: 18 and over

- Performance status: Gait impairment at least grade 2

- Hematopoietic: Not specified

- Hepatic: Not specified

- Renal: Creatinine no greater than 1. 4 mg/dL (women) Creatinine no greater than 1. 5

mg/dL (men) No history of renal failure

- Cardiovascular: No history of cardiac failure

- Neurologic: Normal nerve conduction studies or changes compatible with distal

symmetric diabetic neuropathy or diabetic lumbosacral radioplexus neuropathy Spinal fluid cell count less than 5 cells/mm3 Normal cerebral spinal fluid cytology No structural spine disease No inherited neuropathy

- Other: Electromyographic evidence of proximal lower limb plexus OR Radicular

denervation compatible with proximal diabetic neuropathy No other systemic disease or malignancy Normal IgA levels No chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) No systemic amyloidosis No monoclonal gammopathy associated neuropathy No history of allergy to serum products No selective cervical or root involvement without lower limb weakness No evidence of secondary diabetes

Locations and Contacts

Additional Information

Starting date: February 1998
Last updated: June 23, 2005

Page last updated: June 20, 2008

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