Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Information source: University of Massachusetts, Worcester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple System Atrophy
Intervention: intravenous immunoglobulin (IVIg) (Drug)
Phase: Phase 2
Sponsored by: University of Massachusetts, Worcester
Official(s) and/or principal investigator(s):
Peter Novak, MD, PhD, Principal Investigator, Affiliation: University of Massachusetts, Worcester
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.
Official title: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate safety of the IVIg infusions for treatment of MSA.
Secondary outcome: To evaluate preliminary efficacy of IVIg for treatment of MSA.
Minimum age: 18 Years.
Maximum age: N/A.
1. Male or female older than 17 years.
2. Clinical diagnosis of probable multiple system atrophy
3. Provide written informed consent to participate in the study
4. Understand that they may withdraw their consent at any time
1. Women who are pregnant or lactating
2. In the investigator's opinion, have any other significant systemic, hepatic, cardiac
or renal illness.
3. In the investigator's opinion, the subjects are significantly dehydrated, as
determined by clinical evaluation including measurement of skin turgor, BUN and Cr
Locations and Contacts
University of Massachusetts Medical School, Worcester, Massachusetts 01655, United States
Starting date: June 2008
Last updated: December 5, 2013