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Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

Information source: University of Massachusetts
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple System Atrophy

Intervention: intravenous immunoglobulin (IVIg) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Massachusetts

Official(s) and/or principal investigator(s):
Peter Novak, MD, PhD, Principal Investigator, Affiliation: University of Massachusetts

Overall contact:
Arlene Williams, RN, Phone: 508-856-5243, Email: Arlene.Williams@umassmed.edu

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.

Clinical Details

Official title: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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 values.

Locations and Contacts

Arlene Williams, RN, Phone: 508-856-5243, Email: Arlene.Williams@umassmed.edu

University of Massachusetts Medical School, Worcester, Massachusetts 01655, United States; Recruiting
Additional Information

Starting date: June 2008
Ending date: May 2010
Last updated: September 9, 2008

Page last updated: October 19, 2009

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