Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention: Immune globulin (Drug)
Phase: Phase 3
Sponsored by: National Center for Research Resources (NCRR)
Official(s) and/or principal investigator(s):
Jerry R. Mendell, Study Chair, Affiliation: Ohio State University
I. Compare the response of previously untreated patients with chronic inflammatory
demyelinating polyneuropathy to intravenous immune globulin vs. placebo.
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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.
Minimum age: 15 Years.
Maximum age: N/A.
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
Locations and Contacts
Starting date: September 1992
Last updated: June 23, 2005