|
Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy Clinical research trials and Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy. Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy clinical trial. Participants frequently get the best healthcare available for their Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy  Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy
Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy
For Condition: Diabetic Neuropathies
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Mayo Clinic
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 75
Location and Contact Information:
Overall Study Official:
AnthonyWindebank, Study Chair, Mayo Clinic
Additional Information:
Study ID Numbers: 199/13294; MAYOC-91596,MAYOC-FDR001358
Study Start Date: February 1998
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004407
Other Diabetic Neuropathies Studies:
1. Treatment of Peripheral Neuropathy in Patients with Diabetes.
2. Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy
3. Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes.
4. LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes.
5. Tolerability of Three Local Anesthetic Formulations in Conjunction with NGX-4010 for the Treatment of Neuropathic Pain
Related Studies:
Other Diabetic Neuropathies Clinical Trials
Other Clinical Trials
Other Clinical Trials
Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients with Subacute Proximal Diabetic Neuropathy
|
|
|
|
|
|
|
|
