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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

Status: Completed

Sponsored by: University of Massachusetts, Worcester

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

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: 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.

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

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

Starting date: June 2008
Last updated: December 5, 2013

Page last updated: August 23, 2015

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