Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Status Terminated

Clinical Trial Summary

OBJECTIVES:

I. Determine whether intravenous immunoglobulin is an effective therapy for patients with mild or moderate myasthenia gravis.

Clinical Trial Description

PROTOCOL OUTLINE: This study is a randomized, blinded, controlled study. Patients are stratified in both groups according to prior thymectomy (yes vs no) and by Quantitative Myasthenia Gravis Score (equal to or less than 10 vs greater than 10) so that equal numbers are assigned to each group. Patients in group 2 are also stratified as to whether they are currently on azathioprine.

Patients are randomized to receive either intravenous immunoglobulin (IVIG) for 2 days or 5% albumin (the placebo) for 2 days. A second infusion of IVIG for 1 day or albumin placebo for 1 day is given on day 22.

At the end of 6 weeks, after the randomized study, patients may choose to receive 3 additional IVIG infusions.

Patients are followed on days 1, 21, 32, and 42 of randomized or open label study.

Completion date provided represents the completion date of the grant per OOPD records ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myasthenia Gravis

• NCT number: NCT00004682
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Terminated
• Phase: N/A
• Start date: March 1995
• Completion date: March 1999