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NCT02307877 · ClinicalTrials.gov registry record

Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate

A clinical trial of Multiple Sclerosis, sponsored by University of Colorado, Denver.

Completed
Registry status
157
Enrollment target
1
Study location

NCT02307877 is a study of Multiple Sclerosis that has completed, run by University of Colorado, Denver. The registered enrollment target is 157 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02307877, a study of Multiple Sclerosis, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
157 participants
Enrollment target
1
Study location

Study Summary

Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into whether there is continued progression of MS in these patients. What remains unknown is whether patients on a particular therapy have a slower rate of brain atrophy. This would provide convincing evidence that central nervous system tissue injury is further suppressed. Such information would be of substantial clinical benefit when deciding between various therapies. The investigators will estimate the impact of long term use of fingolimod therapy (defined as a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing forms of MS as compared to age and gender matched patients on Glatiramer Acetate. The investigators secondary goal is to determine the correlation between brain atrophy and cognitive performance in treated patients with relapsing forms of MS. The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL) PROs, patient self-reports of disability, clinical assessment of physical disability, work productivity, clinical assessments of cognitive functioning with whole brain volume loss for patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and gender. The investigators anticipate the findings of this study will generate relevant hypotheses about these relationships.

Conditions Studied

Study Locations (1)

Colorado

  • University of Colorado Hospital - Aurora

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2014-09
Est. Completion 2018-05

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT02307877

The ClinicalTrials.gov registry entry for NCT02307877 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (73% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 0 interventions.

NCT02307877 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT02307877 about?

NCT02307877 is a clinical study titled "Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate". Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad les...

What is the current status of trial NCT02307877?

This trial is currently completed. The enrollment target is 157 participants. The study started on 2014-09. Estimated completion is 2018-05.

What conditions does trial NCT02307877 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

Who is sponsoring clinical trial NCT02307877?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02307877 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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