Search / Trial NCT00001287

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

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Dec 9, 2002

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Intravenous High Dose Immunoglobulin Monoclonal Gammopathies Peripheral Nerve Demyelination Cidp Chronic Inflammatory Demyelinating Polyneuropathy

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. Alth...

Gender

All

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.

Attachments

readout_NCT00001287_2024-03-02.pdf

4.5 MB

NCT00001287_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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