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Sponsored by: |
University of Massachusetts |
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Information provided by: | University of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00750867 |
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.
Condition | Intervention | Phase |
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Multiple System Atrophy |
Drug: intravenous immunoglobulin (IVIg) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins |
Estimated Enrollment: | 10 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: intravenous immunoglobulin (IVIg)
The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arlene Williams, RN | 508-856-5243 | Arlene.Williams@umassmed.edu |
United States, Massachusetts | |
University of Massachusetts Medical School | Recruiting |
Worcester, Massachusetts, United States, 01655 |
Principal Investigator: | Peter Novak, MD, PhD | University of Massachusetts |
Responsible Party: | University of Massachusetts ( Peter Novak, MD, PhD ) |
Study ID Numbers: | H-12784 |
Study First Received: | September 9, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00750867 History of Changes |
Health Authority: | United States: Food and Drug Administration |
multiple system atrophy, MSA, intravenous immunoglobulin, IVIg |
Pathological Conditions, Anatomical Ganglion Cysts Immunologic Factors Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Antibodies Multiple System Atrophy Movement Disorders Immunoglobulins, Intravenous Rho(D) Immune Globulin Atrophy Immunoglobulins |
Pathological Conditions, Anatomical Immunologic Factors Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Pharmacologic Actions Antibodies Multiple System Atrophy Movement Disorders Immunoglobulins, Intravenous Rho(D) Immune Globulin Atrophy Immunoglobulins |