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Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Primary Purpose

Demyelinating Diseases, Paraproteinemias

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
intravenous immunoglobulin (IVIg)
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Demyelinating Diseases focused on measuring Intravenous High-Dose Immunoglobulin, Monoclonal Gammopathies, Peripheral Nerve Demyelination, CIDP, Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Selected patients should have CIDP with or without an associated monoclonal gammopathy. Subjects should have clinical evidence of peripheral neuropathy with muscle weakness and sensory deficit. Subjects should have evidence of clinical, histological or family history of another neuromuscular illness. Subjects should have elevation of CSF protein during the course of the disease. Subjects should have demyelination by nerve conduction study and/or nerve biopsy. Suitable candidates for IVIg should be patients with active, bonefide CIDP who: have been treated with steroids but had: a) no response or incomplete response (as defined by continued muscle weakness) to high-dose therapy or b) a good response to steroids but inability to taper the dose without a flare of disease activity or c) unacceptable steroid side effects such as gastrointestinal hemorrhages, osteonecrosis, hyperglycemia, extreme weight gain etc. or have been additionally treated with one of the other immunosuppressive agents considered effective in some CIDP patients, such as azathioprine, chlorambucil, cyclophosphamide, cyclosporine or plasmapheresis but without benefit or with unacceptable side effects that had necessitated their discontinuation. Subjects should not be pregnant or nursing. Subjects should not be critically ill such as those requiring intravenous pressors for maintenance of cardiac output, patients with unstable respiratory insufficiency and patients with such severe muscle weakness requiring help for basic self care (Karnofsky performance scale less than 50). No subjects below 18 years of age. Patients should not have severe renal or hepatic disease and severe COPD or coronary artery disease. Patients should not be allergic to IVIg or have a known IgA deficiency.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001287
Brief Title
Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Official Title
The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
December 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
Chronic Inflammatory Demylinating Polyneuropathy (CIDP) is an autoimmune condition affecting the nervous system. Researchers believe the immune system begins attacking the cells covering nerves called myelin. The destruction of myelin causes muscle weakness, loss of sensation, abnormal levels of protein in the fluid surrounding the brain (CSF), and slowing of the nervous system. The disease progresses slowly and disables patients suffering from it. CIDP is treated with steroids, plasmapheresis, and immunosuppressive drugs. Many patients initially respond to these treatments, but develop resistance to the therapy or experience side effects causing the treatments to be stopped. Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with CIDP a safer and more effective alternative to standard therapies for the disease. IVIg is a drug that has been used successfully to treat other immune-related diseases of the nervous system. However, because IVIg is so expensive, researchers believe it should first be proven effective on a small group of patients. The study will take 60 patients with CIDP and divide them into two groups. Group one will receive 2 injections of IVIg once a month for three months. Group two will receive 2 injections of placebo "inactive injection of sterile water" once a month for three months. Following the three months of treatment, group one will begin taking the placebo and group two will begin taking IVIg for an additional 3 months. The drug will be considered effective if patients receiving it experience a significant improvement (>25%) in muscle strength.
Detailed Description
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a slowly progressive disabling neuropathy characterized by subacute onset of muscle weakness, distal sensory deficit, elevated spinal fluid protein, and slow nerve conduction velocity with or without conduction block. A monoclonal gammopathy is at times present in the serum of some patients. Because immune-mediated mechanisms against peripheral nerve myelin are thought to be primarily responsible for the clinical manifestations of CIDP, the treatment of choice is with corticosteroids, plasmapheresis or immunosuppressive drugs. Although many patients initially respond to these agents, a large number of them become resistant or develop unacceptable side effects that necessitate their discontinuation. The need for a more effective and safe immunotherapy in CIDP patients prompted the present study using high-dose intravenous immunoglobulin (IVIg). IVIg is an immunomodulating agent which has been recently shown to be effective and safe in the treatment of a number of patients with immune-related neuromuscular diseases. This is a double blind, randomized, placebo controlled, trial involving 60 patients, half of which will receive IVIg and the other half placebo (D5/W). Because IVIg is prohibitively expensive, a controlled trial is needed to provide convincing evidence of efficacy, and ensure that the benefit is not due to spontaneous improvement or to observer bias. The dose of IVIg is 2 GM/Kg divided into two daily doses administered monthly for six months. The drug will be considered effective if patients experience an increase of more than 25% in their baseline muscle strength. Muscle strength will be assessed with a series of objective dynamometric measurements performed before and after each monthly infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Demyelinating Diseases, Paraproteinemias
Keywords
Intravenous High-Dose Immunoglobulin, Monoclonal Gammopathies, Peripheral Nerve Demyelination, CIDP, Chronic Inflammatory Demyelinating Polyneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravenous immunoglobulin (IVIg)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Selected patients should have CIDP with or without an associated monoclonal gammopathy. Subjects should have clinical evidence of peripheral neuropathy with muscle weakness and sensory deficit. Subjects should have evidence of clinical, histological or family history of another neuromuscular illness. Subjects should have elevation of CSF protein during the course of the disease. Subjects should have demyelination by nerve conduction study and/or nerve biopsy. Suitable candidates for IVIg should be patients with active, bonefide CIDP who: have been treated with steroids but had: a) no response or incomplete response (as defined by continued muscle weakness) to high-dose therapy or b) a good response to steroids but inability to taper the dose without a flare of disease activity or c) unacceptable steroid side effects such as gastrointestinal hemorrhages, osteonecrosis, hyperglycemia, extreme weight gain etc. or have been additionally treated with one of the other immunosuppressive agents considered effective in some CIDP patients, such as azathioprine, chlorambucil, cyclophosphamide, cyclosporine or plasmapheresis but without benefit or with unacceptable side effects that had necessitated their discontinuation. Subjects should not be pregnant or nursing. Subjects should not be critically ill such as those requiring intravenous pressors for maintenance of cardiac output, patients with unstable respiratory insufficiency and patients with such severe muscle weakness requiring help for basic self care (Karnofsky performance scale less than 50). No subjects below 18 years of age. Patients should not have severe renal or hepatic disease and severe COPD or coronary artery disease. Patients should not be allergic to IVIg or have a known IgA deficiency.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7224612
Citation
Dalakas MC, Engel WK. Chronic relapsing (dysimmune) polyneuropathy: pathogenesis and treatment. Ann Neurol. 1981;9 Suppl:134-45. doi: 10.1002/ana.410090719.
Results Reference
background
PubMed Identifier
2153942
Citation
Cook D, Dalakas M, Galdi A, Biondi D, Porter H. High-dose intravenous immunoglobulin in the treatment of demyelinating neuropathy associated with monoclonal gammopathy. Neurology. 1990 Feb;40(2):212-4. doi: 10.1212/wnl.40.2.212.
Results Reference
background
PubMed Identifier
7962520
Citation
Basta M, Dalakas MC. High-dose intravenous immunoglobulin exerts its beneficial effect in patients with dermatomyositis by blocking endomysial deposition of activated complement fragments. J Clin Invest. 1994 Nov;94(5):1729-35. doi: 10.1172/JCI117520.
Results Reference
background

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Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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