A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years (TST)
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|ClinicalTrials.gov Identifier: NCT01847287|
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : May 7, 2013
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||A Prospective, Observational, Single-blinded, Longitudinal Study of Natalizumab Effect on Brain Atrophy and Disability in Multiple Sclerosis Patients Over 5 Years.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
All subjects took Tysabri and also had an MRI which we use for the baseline evaluation. Over 5 years, some patients remained on Tysabri, some started another drug and others were off Tysabri for a time but then restarted.
- The primary aim of this study is to define the effect of the number of natalizumab cycles on development of brain atrophy and progression of disability in originally treated patients with natalizumab in relapsing multiple sclerosis (MS). [ Time Frame: 5 years ]Evaluation of MRI images from baseline in comparison with a 5 year MRI.
- The secondary objective of this study is to define the effect of the number of natalizumab cycles on accumulation of T2-LV and T1-LV and their VW-MTR changes over 5 years. [ Time Frame: 5 years ]To evaluate any effect of the number of Tysabri cycles on lesion volume.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847287
|United States, New York|
|Buffalo Neuroimaging Analysis Center|
|Buffalo, New York, United States, 14203|