Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01881191 : Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
PhaseN/A
AgesMin: 18 Years Max: 65 Years
Eligibility
Inclusion Criteria:

- 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 Criteria:

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01881191      |      Link to official Clinicaltrials.gov listing
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