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

NCT02588053 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2019-04-17

No results posted yet for this study

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).

Conditions

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Augusto Miravalle, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-12-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02588053 on ClinicalTrials.gov