Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004772|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.
|Condition or disease||Intervention/treatment||Phase|
|Polyradiculoneuropathy, Chronic Inflammatory Demyelinating||Drug: Immune globulin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Study Start Date :||September 1992|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004772
|Study Chair:||Jerry R. Mendell||Ohio State University|