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

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

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, 85741, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MSDX Complex-1 Biomarker test

Other

MSDX Complex-1 Biomarker test

Other names: Biomarker Test

Primary outcomes

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

Time frame: 6 months

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.

Secondary outcomes

Gadolinium MRI and MSDX Complex-1 level

Time frame: 6 months

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.

Sponsors and collaborators

Lead sponsor

MSDx, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 1, 2012
Registry last updated: Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed