Full Text View
Tabular View
No Study Results Posted
Related Studies
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
This study has been completed.
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Center for Research Resources (NCRR)
Ohio State University
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004772
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Drug: Immune globulin
Phase III

Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 90
Study Start Date: September 1992
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004772

Sponsors and Collaborators
Ohio State University
Investigators
Study Chair: Jerry R. Mendell Ohio State University
  More Information

No publications provided

Study ID Numbers: 199/11794, OSU-92H0250
Study First Received: February 24, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004772     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
demyelinating neuropathy
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Polyradiculoneuropathy
Polyneuropathies
Rare Diseases
Chronic Inflammatory Demyelinating Polyneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Antibodies
Neuromuscular Diseases
Immunoglobulins, Intravenous
Mental Disorders
Peripheral Nervous System Diseases
Rho(D) Immune Globulin
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Polyradiculoneuropathy
Physiological Effects of Drugs
Nervous System Diseases
Polyneuropathies
Pharmacologic Actions
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Antibodies
Neuromuscular Diseases
Immunoglobulins, Intravenous
Peripheral Nervous System Diseases
Autoimmune Diseases of the Nervous System
Immunoglobulins

ClinicalTrials.gov processed this record on May 07, 2009