NCT01847287

A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years

A Prospective, Observational, Single-blinded, Longitudinal Study of Natalizumab Effect on Brain Atrophy and Disability in Multiple Sclerosis Patients Over 5 Years.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to evaluate the effect of using Tysabri on changes in the brain using MRI and on disease progression in patients with relapsing-remitting Multiple Sclerosis over 5 years.

Detailed description

This is a prospective, observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy development and disability progression in multiple sclerosis patients over 5 years, which will evaluate originally treated patients with natalizumab who participated in a prospective 1- and 2-year VWMTR study. (Zivadinov et al., 2011b) All subjects will be assessed at 5-year follow-up with the same clinical examinations and will obtain 1.5T MRI examination on the same scanner that did not undergo any upgrade changes in the period of 5 years.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-05-06
• Last updated: 2013-05-07

Locations

1 site across 1 country: United States