Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02588053
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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.
Primary hypothesis:
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 18-55 inclusive years of age at the time of informed consent
- Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria
- Currently taking Tysabri
- Systemic steroid users
- comorbidities that could confound MRI outcomes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Brain Atrophy Rate Baseline, Year 1, and Year 2
- Secondary Outcome Measures
Name Time Method Change in Mean Cortical Thickness Baseline, Year 1, and Year 2 Change in Neocortical Gray Matter Volume Baseline, Year 1, and Year 2 Change in Subcortical Gray Matter Volume Baseline, Year 1, and Year 2
Trial Locations
- Locations (1)
University of Colorado Anschutz
🇺🇸Aurora, Colorado, United States