Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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