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

NCT00001287 | Completed Phase 2

• 2 other identifiers: 91003991-N-0039
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Demyelinating Diseases; Paraproteinemias

Keywords

Intravenous High-Dose Immunoglobulin; Monoclonal Gammopathies; Peripheral Nerve Demyelination; CIDP; Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

intravenous immunoglobulin (IVIg) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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: 1. 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 2. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Dalakas MC, Engel WK. Chronic relapsing (dysimmune) polyneuropathy: pathogenesis and treatment. Ann Neurol. 1981;9 Suppl:134-45. doi: 10.1002/ana.410090719.

  PMID: 7224612 BACKGROUND

• 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.

  PMID: 2153942 BACKGROUND

• 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.

  PMID: 7962520 BACKGROUND

MeSH Terms

Conditions

Demyelinating Diseases; Paraproteinemias; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Nervous System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: December 1, 1990
• Study Completion: January 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-02

Locations

US (1)