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NCT00001248 · ClinicalTrials.gov registry record

Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

A clinical trial of Multiple Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Recruiting
Registry status
3,750
Enrollment target
1
Study location

NCT00001248 is a study of Multiple Sclerosis that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 3,750 participants, above the 573-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (554% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00001248, a study of Multiple Sclerosis, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

RECRUITING
Registry status
3,750 participants
Enrollment target
1
Study location

Study Summary

Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI and immunological measures. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved disease-modifying therapies of MS will be examined. In both cohorts of patients levels of disease activity on MRI will be compared with immunological characteristics in order to help identify disease mechanism. Patients with either definite MS (based either on clinical or combined clinical and MRI criteria) or with an initial presentation of neurological dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI will be assessed using several MRI measures of disease activity including the number of contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to assess axonal damage. Patients will be assessed clinically and correlations between immunological and genetic factors and disease activity as seen clinically or by MRI will be studied. A second cohort of patients starting the use of approved therapy will also be examined. Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity. After beginning approved therapy under the direction of their private physician, patients will be followed similarly to the natural history cohort. Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy. Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state, disease stage or repsonse to therapies. Additionally, a cohort of normal volunteers will be studied. The studies in t

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 3,750 participants
Start Date 1992-07-23

What the Registry Record Tells You About NCT00001248

The ClinicalTrials.gov registry entry for NCT00001248 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 3,750 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 573-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (554% higher). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 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.

NCT00001248 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001248 about?

NCT00001248 is a clinical study titled "Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)". Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI and immunological measures. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved disease-modifying therapies of MS will ...

What is the current status of trial NCT00001248?

This trial is currently recruiting. The enrollment target is 3,750 participants. The study started on 1992-07-23.

What conditions does trial NCT00001248 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

Who is sponsoring clinical trial NCT00001248?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001248 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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