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Monoclonal Antibodies

1 for Multiple System Atrophy

Phase 2
Waitlist Available
Led By Peter Novak, MD, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly, up to 8 months (including the screening visit and the final visit)
Awards & highlights

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.

Eligible Conditions
  • Multiple System Atrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly, up to 8 months (including the screening visit and the final visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly, up to 8 months (including the screening visit and the final visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Adverse Events up to Six Months Post-treatment
Secondary outcome measures
Preliminary Efficacy of IVIg for Treatment of MSA.

Side effects data

From 2012 Phase 2 trial • 9 Patients • NCT00750867
100%
elevated blood pressure
33%
pruritic skin rash
22%
decreased GFR
22%
worsening of allergies
11%
wrist strain
11%
elevated PSA
11%
worsening of sleep apnea
11%
urinary tract infection
11%
Accidental injury
11%
increased temperature or skin flushing
11%
restless leg syndrome
11%
ankle edema
11%
elevated BUN
11%
nodular lung abnormality
11%
low potassium
11%
viral infection of gastrointenstinal tract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label Interventional Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Interventions included monthly infusions of intravenous immunoglobulin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
356 Previous Clinical Trials
992,206 Total Patients Enrolled
Peter Novak, MD, PhDPrincipal InvestigatorUniversity of Massachusetts, Worcester
~1 spots leftby Sep 2025