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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: MRI

• Registration Number: NCT01881191
• Lead Sponsor: University at Buffalo

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 healthy control group will also complete the same testing regimen.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-19
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	MRI	Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire.
Aubagio MRI	MRI	Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire.

Primary Outcome Measures

Name	Time	Method
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.	baseline, 6 month and 12 month

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months.	baseline, month 6 and month 12

Trial Locations

Locations (1)

Buffalo Neuroimaging Analysis Center; 🇺🇸 Buffalo, New York, United States