Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months

Completed

Conditions studied: Multiple Sclerosis

In brief

This study will evaluate the effects of Aubagio on changes in the brain using MRI.

Key facts

Study ID: NCT01881191
Run by: University at Buffalo
People needed: 50
Starts: 2013-06-01
Expected to finish: 2015-10-01
Last updated by the study team: 2016-02-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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