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

This study has been terminated.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004407
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2001

October 18, 1999
March 24, 2015
February 1998
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Complete list of historical versions of study NCT00004407 on ClinicalTrials.gov Archive Site
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Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy
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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.

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

Interventional
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Primary Purpose: Treatment
Diabetic Neuropathies
Drug: immune globulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
March 2000
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004407
199/13294, MAYOC-91596, MAYOC-FDR001358
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Mayo Clinic
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Study Chair: Anthony J. Windebank Mayo Clinic
FDA Office of Orphan Products Development
January 2001

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