6
Participants
Start Date
February 29, 2012
Primary Completion Date
May 31, 2014
Study Completion Date
September 30, 2015
Double blinded IVIg
Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
Double blinded Placebo
Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
Single Blinded IVIg
This is the single blind Second Observation Period. All participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later.
NYU Medical Center, New York
Nih Ninds, Bethesda
Vanderbilt University, Nashville
Mayo Clinic, Rochester
UT Southwestern Medical Center, Dallas
Beth Israel Deaconess Medical Center, Boston
Collaborators (1)
Mayo Clinic
OTHER
Vanderbilt University
OTHER
NYU Langone Health
OTHER
University of Texas Southwestern Medical Center
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Beth Israel Deaconess Medical Center
OTHER