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

Sponsor:

Collaborator:

Mayo Clinic

Information provided by:

FDA Office of Orphan Products Development

ClinicalTrials.gov Identifier:

NCT00004407

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: January 2001

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

February 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00004407 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Neuropathies

Intervention ^ICMJE

Drug: immune globulin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00004407

Other Study ID Numbers ^ICMJE

199/13294, MAYOC-91596, MAYOC-FDR001358

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Mayo Clinic

Investigators ^ICMJE

Study Chair:

Anthony J. Windebank

Mayo Clinic

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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