Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months (GZA)
This study will evaluate the effects of Aubagio on changes in the brain using MRI.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study|
- 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. [ Time Frame: baseline, 6 month and 12 month ] [ Designated as safety issue: No ]
- 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. [ Time Frame: baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum to be retained.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire.
Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881191
|Contact: Robert Zivadinov, MD,PhD,FAANfirstname.lastname@example.org|
|Contact: Cheryl L Kennedy, LMSW, MPHemail@example.com|
|United States, New York|
|Buffalo Neuroimaging Analysis Center||Recruiting|
|Buffalo, New York, United States, 14203|
|Contact: Cheryl L Kennedy, LMSW, MPH 716-859-7068 firstname.lastname@example.org|
|Contact: Rebecca Melia, BS 716-859-7040 email@example.com|
|Principal Investigator: Robert Zivadinov, MD,PhD, FAAN|
|Principal Investigator:||Robert Zivadinov, MD,PhD,FAAN||University at Buffalo|