A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

NCT ID: NCT01541618

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

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tysabri Group

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

MSDX Complex-1 Biomarker test

Intervention Type OTHER

MSDX Complex-1 Biomarker test

Interventions

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MSDX Complex-1 Biomarker test

MSDX Complex-1 Biomarker test

Intervention Type OTHER

Other Intervention Names

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Biomarker Test

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of clinically definite relapsing remitting MS (RRMS)
2. Age 45 years and older
3. Willing and able to provide written informed consent
4. Patient has high disease activity.
5. Patient is about to begin Natalizumab (Tysabri) therapy.

Exclusion Criteria

1. Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS
2. Known infectious or hematological disease.
3. Unwilling or unable to comply with the requirements of this protocol
4. Subject can not have a gadolinium enhanced MRI
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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Jeannette 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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MSDX-0411

Identifier Type: -

Identifier Source: org_study_id

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