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

August 31, 2020 updated by: MSDx, Inc.

A Longitudinal 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Northwest NeuroSpecialists, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study populations for this study is a patient 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Other: MSDX Complex-1 Biomarker test
MSDX Complex-1 Biomarker test
Other Names:
  • Biomarker Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MSDx, Inc.

Investigators

  • Principal Investigator: Jeannette Wendt, MD, Northwest NeuroSpecialists, PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSDX-0411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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