Status:
COMPLETED
Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
Lead Sponsor:
University at Buffalo
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
This study will evaluate the effects of Aubagio on changes in the brain using MRI.
Detailed Description
Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A health...
Eligibility Criteria
Inclusion
- Subjects aged 18-65
- 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
- None of the exclusion criteria
Exclusion
- MS patients with hepatic impairment
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01881191
Start Date
June 1 2013
End Date
October 1 2015
Last Update
February 12 2016
Active Locations (1)
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1
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203