Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

University of Massachusetts, Worcester

Status and phase: Completed; Phase 2

Conditions: Multiple System Atrophy

Treatments: Drug: intravenous immunoglobulin (IVIg)

Study type: Interventional

Funder types: Other

Identifiers

NCT00750867

H-12784

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

1

Experimental group

Description:

Interventions included monthly infusions of intravenous immunoglobulin.

Treatment:

Drug: intravenous immunoglobulin (IVIg)