A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

NCT ID: NCT01539395

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Inactive Disease

Inactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri.

MSDx Complex-1 Biomarker Test

Intervention Type OTHER

A biomarker test for the level of MSDx Complex-1

Active Disease

Active disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months.

MSDx Complex-1 Biomarker Test

Intervention Type OTHER

A biomarker test for the level of MSDx Complex-1

Active Disease - Steroid Therapy

Patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).

MSDx Complex-1 Biomarker Test

Intervention Type OTHER

A biomarker test for the level of MSDx Complex-1

Interventions

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MSDx Complex-1 Biomarker Test

A biomarker test for the level of MSDx Complex-1

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 45 years or older of either gender and of any racial/ethnic group.
2. Subjects must be in generally good health.
3. Subjects must be able and willing to comply with the requirements of the protocol.
4. Must be diagnosed with RRMS
5. Meets the criteria to enter Group 1 or Group 2

Exclusion Criteria

1. Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
2. Subject currently has a condition such as active influenza that would stimulate the immune system
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MSDx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeanette K Wendt, MD

Role: PRINCIPAL_INVESTIGATOR

Northwest NeuroSpecialists, PLLC

Locations

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Northwest NeuroSpecialists, PLLC

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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MSDX0211

Identifier Type: -

Identifier Source: org_study_id

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