Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?
NCT ID: NCT02588053
Last Updated: 2019-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
85 participants
OBSERVATIONAL
2014-07-31
2019-01-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria
* Currently taking Tysabri
Exclusion Criteria
* comorbidities that could confound MRI outcomes
18 Years
55 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Augusto Miravalle, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz
Aurora, Colorado, United States
Countries
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Other Identifiers
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13-2927
Identifier Type: -
Identifier Source: org_study_id
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