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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00750867 |
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Date of registration:
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09/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
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Scientific title:
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Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00750867 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter Novak, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Massachusetts, Worcester |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple System Atrophy
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Intervention(s)
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Drug: intravenous immunoglobulin (IVIg)
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Preliminary Efficacy of IVIg for Treatment of MSA.
[Time Frame: Monthly, up to 8 months (including the screening visit and the final visit)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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