Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy

Study Description

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Brief Summary:

OBJECTIVES:

I. Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.

Condition or disease	Intervention/treatment	Phase
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Drug: Immune globulin	Phase 3

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind study. The first group receives intravenous immune globulin (IVIG) on days 1, 2, and 21; the second group receives an intravenous placebo on the same schedule.

Patients in either group may receive IVIG (same dosage as first group) after day 42.

Concurrent steroids and other immune globulin preparations are prohibited.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	90 participants
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Treatment
Study Start Date :	September 1992

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Chronic inflammatory demyelinating polyneuropathy (CIDP), i.e.: Progressive or relapsing motor and sensory dysfunction of more than 1 limb over at least 2 months Hypo- or areflexia of at least 2 limbs No myelopathy No central demyelination No drug or toxic exposure known to cause peripheral neuropathy --Prior/Concurrent Therapy-- No prior corticosteroids or other immunomodulators for CIDP No prior plasmapheresis At least 30 days since participation in other investigational study At least 6 months since the following: Cyclophosphamide Intravenous immune globulin Cyclosporine Interferon alfa Azathioprine Corticosteroids Orthoclone Tacrolimus --Patient Characteristics-- Hepatic: No hepatitis Renal: Not specified Neurologic: Cerebrospinal fluid (CSF) protein greater than 50 mg/dL CSF cell count less than 10 CSF VDRL negative 3 of the following motor abnormalities by electrophysiology: Reduced conduction velocity in 2 or more motor nerves Less than 80% of normal if amplitude greater than 80% of normal Less than 70% of normal if amplitude less than 80% of normal Conduction block or abnormal temporal dispersion in 1 motor nerve No ulnar or peroneal nerve entrapment Prolonged distal latency in 2 or more nerves Greater than 125% of normal if amplitude greater than 80% of normal Greater than 150% of normal if amplitude less than 80% of normal Absent F-waves or H response (patients aged under 60) or prolonged shortest F-wave latency in 10 to 15 trials in 2 or more motor nerves Other: No hypersensitivity to immune globulin No IgA deficiency No mutilation of hands or feet No retinitis pigmentosa No ichthyosis No disease that would limit neuromuscular assessment No endocrinopathy No connective tissue disease or vasculitis No Lyme disease No malignancy No Castleman's disease No hyper- or hypothyroidism No HIV infection No alcohol or drug abuse No pregnant or nursing women

Contacts and Locations

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Sponsors and Collaborators

National Center for Research Resources (NCRR)

Ohio State University

Investigators

Study Chair:	Jerry R. Mendell	Ohio State University

More Information

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ClinicalTrials.gov Identifier:	NCT00004772 History of Changes
Other Study ID Numbers:	199/11794; OSU-92H0250
First Posted:	February 25, 2000
Last Update Posted:	June 24, 2005
Last Verified:	December 2001

Keywords provided by Office of Rare Diseases (ORD):

demyelinating neuropathy; neurologic and psychiatric disorders; rare disease

Additional relevant MeSH terms:

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases	Immune System Diseases; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunologic Factors; Physiological Effects of Drugs