Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Double-Blind, Placebo Control
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