NCT00004772

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.

Detailed description

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.

Conditions

• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Type	Name	Description
DRUG	Immune globulin

Timeline

• Start date: 1992-09-01
• First posted: 2000-02-25
• Last updated: 2005-06-24