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Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
This study is currently recruiting participants.
Verified by University of Massachusetts, September 2008
First Received: September 9, 2008   No Changes Posted
Sponsored by: University of Massachusetts
Information provided by: University of Massachusetts
ClinicalTrials.gov Identifier: NCT00750867
  Purpose

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
Multiple System Atrophy
Drug: intravenous immunoglobulin (IVIg)
Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
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

Further study details as provided by University of Massachusetts:

Primary Outcome Measures:
  • To evaluate safety of the IVIg infusions for treatment of MSA. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate preliminary efficacy of IVIg for treatment of MSA. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750867

Contacts
Contact: Arlene Williams, RN 508-856-5243 Arlene.Williams@umassmed.edu

Locations
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts
Investigators
Principal Investigator: Peter Novak, MD, PhD University of Massachusetts
  More Information

No publications provided

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

Keywords provided by University of Massachusetts:
multiple system atrophy, MSA,
intravenous immunoglobulin, IVIg

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009