Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy
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.
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Drug: immune globulin
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||February 1996|
|Estimated Study Completion Date:||November 1999|
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.
|Study Chair:||Rup Tandan||University of Vermont|