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NCT03396822 · ClinicalTrials.gov registry record

Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis

A clinical trial of Multiple Sclerosis, sponsored by University of Maryland, Baltimore.

Completed
Registry status
24
Enrollment target
1
Study location

NCT03396822 is a study of Multiple Sclerosis that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 24 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03396822, a study of Multiple Sclerosis, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
24 participants
Enrollment target
1
Study location

Study Summary

Multiple Sclerosis (MS) is an autoimmune disorder of the central nervous system. In MS, inflammation is known to attack areas of the brain, spinal cord, and optic nerves; resulting in disability. Current MRI technology provides an adequate view of the impact of MS on the "white matter" of the brain, which contains many of the connections between neurons. Quantification of lesions in the white matter due to MS are a standard part of clinical trials and clinical care in MS. However, it has long been known that MS not only can affect the white matter, but also the "gray matter," which contains the majority of the nerve cells in the brain and can cause inflammation in the meninges (the protective tissue that surrounds the brain and spinal cord). Autopsy studies have shown that the inflammation seen in the meninges is driven by a B-cells, a subset of white blood cells and that meningeal inflammation may be responsible for damage to the gray matter of the brain. Ocrelizumab is a new treatment for multiple sclerosis. This medication works by targeting and destroying circulating B-cells. It is thought that this may reduce the level of meningeal inflammation in patients with multiple sclerosis. By reducing meningeal inflammation, this medication may result in less damage to the gray matter and subsequently less disability in MS patients. In this study, the investigators will evaluate the use of a method on 7 tesla (7T) MRI to identify inflammation in the meninges as a potential predictor of response to ocrelizumab treatment for multiple sclerosis. Further, the investigators will evaluate if this MRI technique can be used to monitor the long-term effect of the medication on meningeal inflammation and the development of damage to the gray matter of the brain.

Conditions Studied

Interventions

  • DRUG Gadoteridol

Study Locations (1)

Maryland

  • University of Maryland School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-09-24
Est. Completion 2023-05-25

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT03396822

The ClinicalTrials.gov registry entry for NCT03396822 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 24 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 (96% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Gadoteridol is the first listed.

NCT03396822 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03396822 about?

NCT03396822 is a clinical study titled "Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis". Multiple Sclerosis (MS) is an autoimmune disorder of the central nervous system. In MS, inflammation is known to attack areas of the brain, spinal cord, and optic nerves; resulting in disability. Current MRI technology provides an adequate view of the impact of MS on the "white matter" of the brain,...

What is the current status of trial NCT03396822?

This trial is currently completed. The enrollment target is 24 participants. The study started on 2018-09-24. Estimated completion is 2023-05-25.

What conditions does trial NCT03396822 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT03396822?

The interventions under investigation include: Gadoteridol (DRUG).

Who is sponsoring clinical trial NCT03396822?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03396822 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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