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Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter Novak, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00750867
First received: September 9, 2008
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

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: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

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

No publications provided by University of Massachusetts, Worcester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter Novak, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00750867     History of Changes
Other Study ID Numbers: H-12784
Study First Received: September 9, 2008
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Shy-Drager Syndrome
Multiple System Atrophy
Atrophy
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 Hypotension
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013