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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004772
• Date of registration: 24/02/2000
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
• Date of first enrolment: September 1992
• Target sample size: 90
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004772
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: Jerry R. Mendell
• Affiliation: Ohio State University

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention(s)

Drug: Immune globulin

Secondary ID(s)

199/11794

OSU-92H0250

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ohio State University