Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Conditions
Keywords
demyelinating neuropathy, neurologic and psychiatric disorders, rare disease
Brief summary
OBJECTIVES: I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.
Detailed description
PROTOCOL OUTLINE: This is a double blind, randomized, controlled study. Patients receive either intravenous human immune globulin (IVIG) or placebo infused at a rate of 40 mL/hr, increasing every 30 min to a maximum of 100 mL/hr daily over 6 to 8 hours for 2 days. On day 2, infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1. On day 21, patients receive another IVIG or placebo infusion. Following day 42, patients may choose to continue infusions of IVIG every 21 days for 2 doses. Patients not receiving additional treatment are released from study. Patients are evaluated on days 10, 21, and 43.
Interventions
DRUGimmune globulin
Sponsors
University of Vermont
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by: Progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts Acquired demyelination on electrophysiologic studies Segmental demyelination on nerve histology --Patient Characteristics-- * Not pregnant No significant medical disorders
Outcome results
None listed