Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
Phase 3
Completed
- Conditions
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Registration Number
- NCT00004772
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method