Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?

Completed

Conditions studied: Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT02588053

Run by

University of Colorado, Denver

People needed

85

Starts

2014-07-01

Expected to finish

2019-01-01

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Systemic steroid users
• comorbidities that could confound MRI outcomes

Where it is running

• University of Colorado Anschutz — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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