Recruitment

Recruitment Status
Completed

Inclusion Criterias

Expanded Disability Status Scale (EDSS) scores ≤5.5
Clinically definite MS according to the Polman criteria, 52
Normal kidney function (creatinine clearance >59 mL/min) (patients only)
...
Expanded Disability Status Scale (EDSS) scores ≤5.5
Clinically definite MS according to the Polman criteria, 52
Normal kidney function (creatinine clearance >59 mL/min) (patients only)
None of the exclusion criteria
Signed informed consent
Relapsing MS or Healthy Control (no neurological disorders)
Disease duration <30 years
Subjects aged 18-65

Exclusion Criterias

A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
Nursing mothers or pregnant women who will need to undergo 12 months follow-up
Patients currently treated with leflunomide
...
A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
Nursing mothers or pregnant women who will need to undergo 12 months follow-up
Patients currently treated with leflunomide
Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
MS patients with hepatic impairment
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
Other pathology related to MRI abnormalities
Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
Women of childbearing potential not using reliable contraception

Summary

Conditions
Multiple Sclerosis
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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.

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.

Inclusion Criterias

Expanded Disability Status Scale (EDSS) scores ≤5.5
Clinically definite MS according to the Polman criteria, 52
Normal kidney function (creatinine clearance >59 mL/min) (patients only)
...
Expanded Disability Status Scale (EDSS) scores ≤5.5
Clinically definite MS according to the Polman criteria, 52
Normal kidney function (creatinine clearance >59 mL/min) (patients only)
None of the exclusion criteria
Signed informed consent
Relapsing MS or Healthy Control (no neurological disorders)
Disease duration <30 years
Subjects aged 18-65

Exclusion Criterias

A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
Nursing mothers or pregnant women who will need to undergo 12 months follow-up
Patients currently treated with leflunomide
...
A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
Nursing mothers or pregnant women who will need to undergo 12 months follow-up
Patients currently treated with leflunomide
Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
MS patients with hepatic impairment
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
Other pathology related to MRI abnormalities
Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
Women of childbearing potential not using reliable contraception

Locations

Buffalo, New York, 14203
Buffalo, New York, 14203

Tracking Information

NCT #
NCT01881191
Collaborators
Not Provided
Investigators
  • Principal Investigator: Robert Zivadinov, MD,PhD,FAAN University at Buffalo
  • Robert Zivadinov, MD,PhD,FAAN University at Buffalo