Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
NCT ID: NCT01881191
Last Updated: 2016-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2013-06-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Aubagio MRI
Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire.
MRI
Healthy controls
Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire.
MRI
Interventions
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MRI
Eligibility Criteria
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Inclusion Criteria
* Clinically definite MS according to the Polman criteria, 52
* Relapsing MS or Healthy Control (no neurological disorders)
* Expanded Disability Status Scale (EDSS) scores ≤5.5
* Disease duration \<30 years
* Normal kidney function (creatinine clearance \>59 mL/min) (patients only)
* Signed informed consent
Exclusion Criteria
* Nursing mothers or pregnant women who will need to undergo 12 months follow-up
* Women of childbearing potential not using reliable contraception
* Patients currently treated with leflunomide
* Serum alanine aminotransferase (ALT) \>1.5 times the upper limit of normal
* A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
* Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
* Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
* Other pathology related to MRI abnormalities
18 Years
65 Years
ALL
Yes
Sponsors
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University at Buffalo
OTHER
Responsible Party
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Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
Principal Investigators
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Robert Zivadinov, MD,PhD,FAAN
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Locations
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Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States
Countries
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Other Identifiers
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GZ-2013-10958
Identifier Type: -
Identifier Source: org_study_id
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