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Trial record 3 of 202 for:    Cerebral Atrophy

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

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ClinicalTrials.gov Identifier: NCT02588053
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease
Multiple Sclerosis

Study Type : Observational
Estimated Enrollment : 146 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)? A Longitudinal Study Using Whole Brain, Neocortical and Subcortical Atrophy Rates and Patient Reported Outcomes (PROs).
Actual Study Start Date : July 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab




Primary Outcome Measures :
  1. Change in Brain Atrophy Rate [ Time Frame: Baseline, Year 1, and Year 2 ]

Secondary Outcome Measures :
  1. Change in Mean Cortical Thickness [ Time Frame: Baseline, Year 1, and Year 2 ]
  2. Change in Neocortical Gray Matter Volume [ Time Frame: Baseline, Year 1, and Year 2 ]
  3. Change in Subcortical Gray Matter Volume [ Time Frame: Baseline, Year 1, and Year 2 ]

Other Outcome Measures:
  1. Change in Patient-reported Quality of Life [ Time Frame: Baseline, Year 1, and Year 2 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Relapsing Multiple Sclerosis and Healthy Controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588053


Locations
United States, Colorado
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Augusto Miravalle, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02588053     History of Changes
Other Study ID Numbers: 13-2927
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Atrophy
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathological Conditions, Anatomical
Natalizumab
Immunologic Factors
Physiological Effects of Drugs