Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy
Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Neuropathies
Intervention: immune globulin (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Mayo Clinic 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: Primary Purpose: 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.
Completion date provided represents the completion date of the grant per OOPD records
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: March 24, 2015
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