Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy
Summary
The purpose of the study is to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Multifocal Motor Neuropathy
Intervention
Immune Globulin Intravenous, 10%, Immune Globulin Intravenous, 10% or Placebo (0.25% human albumin solution)
Location
University of Alabama
Birmingham
Alabama
United States
35294-0017
Status
Recruiting
Source
Baxter Healthcare Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00666263
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Rho(d) Immune Globulin
Immunizing agent containing IMMUNOGLOBULIN G anti-Rho(D) used for preventing Rh immunization in Rh-negative individuals exposed to Rh-positive red blood cells.
Shwartzman Phenomenon
Hemorrhagic necrosis that was first demonstrated in rabbits with a two-step reaction, an initial local (intradermal) or general (intravenous) injection of a priming endotoxin (ENDOTOXINS) followed by a second intravenous endotoxin injection (provoking agent) 24 h later. The acute inflammation damages the small blood vessels. The following intravascular coagulation leads to capillary and venous THROMBOSIS and NECROSIS. Shwartzman phenomenon can also occur in other species with a single injection of a provoking agent, and during infections or pregnancy. Its susceptibility depends on the status of IMMUNE SYSTEM, coagulation, FIBRINOLYSIS, and blood flow.
Progesterone-binding Globulin
A glycoprotein migrating as alpha 1-globulin, molecular weight 70,000 to 120,000. The protein, which is present in increased amounts in the plasma during pregnancy, binds mainly progesterone, with other steroids including testosterone competing weakly.
Tuftsin
N(2)-((1-(N(2)-L-Threonyl)-L-lysyl)-L-prolyl)-L-arginine. A tetrapeptide produced in the spleen by enzymatic cleavage of a leukophilic gamma-globulin. It stimulates the phagocytic activity of blood polymorphonuclear leukocytes and neutrophils in particular. The peptide is located in the Fd fragment of the gamma-globulin molecule.
Sex Hormone-binding Globulin
A glycoprotein migrating as a beta-globulin. Its molecular weight, 52,000 or 95,000-115,000, indicates that it exists as a dimer. The protein binds testosterone, dihydrotestosterone, and estradiol in the plasma. Sex hormone-binding protein has the same amino acid sequence as ANDROGEN-BINDING PROTEIN. They differ by their sites of synthesis and post-translational oligosaccharide modifications.
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