Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?
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|ClinicalTrials.gov Identifier: NCT02588053|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : December 15, 2017
Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing the progression of whole brain atrophy. Whole brain atrophy rates will be measured through magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy controls. The primary outcome will be whole brain atrophy rate measured as the percent change in brain volume (PBVC) over a two-year period.
The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a true "disease activity free" state).
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||146 participants|
|Official Title:||Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)? A Longitudinal Study Using Whole Brain, Neocortical and Subcortical Atrophy Rates and Patient Reported Outcomes (PROs).|
|Actual Study Start Date :||July 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||November 2018|
- Change in Brain Atrophy Rate [ Time Frame: Baseline, Year 1, and Year 2 ]
- Change in Mean Cortical Thickness [ Time Frame: Baseline, Year 1, and Year 2 ]
- Change in Neocortical Gray Matter Volume [ Time Frame: Baseline, Year 1, and Year 2 ]
- Change in Subcortical Gray Matter Volume [ Time Frame: Baseline, Year 1, and Year 2 ]
- Change in Patient-reported Quality of Life [ Time Frame: Baseline, Year 1, and Year 2 ]
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): NCT02588053
|United States, Colorado|
|University of Colorado Anschutz|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Augusto Miravalle, MD||University of Colorado, Denver|