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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541618
• Other study ID #: MSDX-0411
• Status: Completed
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2012
• Source: MSDx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MSDX Complex-1 Biomarker test
MSDX Complex-1 Biomarker test

Locations

Country	Name	City	State
United States	Northwest NeuroSpecialists, PLLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MSDx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months