Multiple Sclerosis Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Systemic steroid users
comorbidities that could confound MRI outcomes

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

85

Study ID:

NCT02588053

Recruitment Status:

Completed

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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University of Colorado Anschutz
Aurora Colorado, 80045, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

85

Study ID:

NCT02588053

Recruitment Status:

Completed

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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