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

University at Buffalo

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT01881191

GZ-2013-10958

Details and patient eligibility

About

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

Full 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 healthy control group will also complete the same testing regimen.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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