Phase 2
N=9
Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Multiple System Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT00750867 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Number of Adverse Events up to Six Months Post-treatment — 43; 0 Adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- intravenous immunoglobulin (IVIg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events up to Six Months Post-treatment |
43; 0 | — |
| SECONDARY Preliminary Efficacy of IVIg for Treatment of MSA. |
23.8; 26.1; 19; 23.3 | 0.0128 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female older than 17 years.
- Clinical diagnosis of probable multiple system atrophy
- Provide written informed consent to participate in the study
- Understand that they may withdraw their consent at any time
Exclusion Criteria
- Women who are pregnant or lactating
- In the investigator's opinion, have any other significant systemic, hepatic, cardiac or renal illness.
- 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.
Data sourced from ClinicalTrials.gov (NCT00750867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.