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Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

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ClinicalTrials.gov Identifier: NCT00750867
Recruitment Status : Completed
First Posted : September 11, 2008
Results First Posted : October 26, 2015
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Peter Novak, University of Massachusetts, Worcester

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: intravenous immunoglobulin (IVIg) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Study Start Date : June 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Interventions included monthly infusions of intravenous immunoglobulin.
Drug: intravenous immunoglobulin (IVIg)
The intravenous immunoglobulin (brand Privigen) will be infused intravenously, monthly, 6 times, for 6 months the dose will be 0.4 gram/kg for each infusion.
Other Name: Privigen

Primary Outcome Measures :
  1. Number of Adverse Events up to Six Months Post-treatment [ Time Frame: Monthly, up to 8 months (including the screening visit and the final visit) ]
    The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.

Secondary Outcome Measures :
  1. Preliminary Efficacy of IVIg for Treatment of MSA. [ Time Frame: Monthly, up to 8 months (including the screening visit and the final visit) ]
    The secondary outcome measure was to evaluate the preliminary efficacy of IVIG for the treatment of MSA. The primary efficacy endpoint was change of the Unified MSA Rating Scale (UMSARS-I and UMSAR-II) compared to baseline. UMSARS-I and UMSARS-II are validated semiquantitative rating scales for evaluation of severity of MSA. UMSARS-I comprises a historical review of disease-related impairments and UMSARS-II comprises motor examination. UMSARS-I has 12 questions, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-I is 0 to 48. UMSARS-II has 12 items rated by an examiner, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-II is 0 to 56. The scores of UMSARS-I and UMSARS-II at baseline (month 1) was compared with the scores obtained at the final visit (month 8) which was 8 months apart. The interventions occured at months 2-7, total six times.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, blood urea nitrogen and creatinine values.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750867

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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
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Principal Investigator: Peter Novak, MD, PhD University of Massachusetts, Worcester
Publications of Results:
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Responsible Party: Peter Novak, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00750867    
Other Study ID Numbers: H-12784
First Posted: September 11, 2008    Key Record Dates
Results First Posted: October 26, 2015
Last Update Posted: February 23, 2017
Last Verified: September 2015
Keywords provided by Peter Novak, University of Massachusetts, Worcester:
multiple system atrophy, MSA,
intravenous immunoglobulin, IVIg
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs