Clinical Trial: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Brief Summary:
Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only and does not alter the course of disease.
Although the cause of MSA remains unclear, there is evidence of presence of common neuroinflammatory mechanisms in the MSA brains including activation of microglia and production of toxic cytokines. This research protocol is based on hypothesis that the MSA progression can be altered by blocking the neuroinflammatory activity.
This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains antibodies derived from human plasma which can block the inflammatory responses in the brain that can lead to loss of brain cells.
Detailed Summary:
Sponsor: University of Massachusetts, Worcester
Current Primary Outcome: Number of Adverse Events up to Six Months Post-treatment [ Time Frame: Monthly, up to 8 months (including the screening visit and the final visit) ]
Original Primary Outcome: To evaluate safety of the IVIg infusions for treatment of MSA. [ Time Frame: Monthly ]
Current Secondary Outcome: Preliminary Efficacy of IVIg for Treatment of MSA. [ Time Frame: Monthly, up to 8 months (including the screening visit and the final visit) ]
Original Secondary Outcome: To evaluate preliminary efficacy of IVIg for treatment of MSA. [ Time Frame: Monthly ]
Information By: University of Massachusetts, Worcester
Dates:
Date Received: September 9, 2008
Date Started: June 2008
Date Completion:
Last Updated: January 5, 2017
Last Verified: September 2015