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

MSDx, Inc.15 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

MSDX Complex-1 Biomarker testOTHER

MSDX Complex-1 Biomarker test

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Change in MSDX Complex-1 between baseline and 6-month visit

This outcome measure will evaluate a difference in the level of MSDX Complex-1 form the baseline visit to the 6-month visit. MSDX Complex-1 is a biomarker for MS disease activity and its change should correspond with a change in the disease activity in MS.

Time frame: 6 months

Secondary Outcomes

Gadolinium MRI and MSDX Complex-1 level

This outcome will evaluate whether a change seen in a Gadolinium MRI (a diagnostic test for MS) matches with a change in the MSDX Complex-1 level in a patient with MS.

Time frame: 6 months

Data from ClinicalTrials.gov

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