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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2001 by FDA Office of Orphan Products Development. Recruitment status was Active, not recruiting

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Mayo Clinic
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004407

Purpose

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
Diabetic Neuropathies	Drug: immune globulin

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	75
Study Start Date:	February 1998

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004407

Sponsors and Collaborators

FDA Office of Orphan Products Development

Mayo Clinic

Investigators

Study Chair:

Anthony J. Windebank

Mayo Clinic

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004407 History of Changes
Other Study ID Numbers:	199/13294, MAYOC-91596, MAYOC-FDR001358
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

diabetic amyotrophy
diabetic lumbosacral radiculoplexus neuropathy
diabetic neuropathy

diabetic proximal neuropathy
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:

Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012