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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis|
- Change in MSDX Complex-1 between baseline and 6-month visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Gadolinium MRI and MSDX Complex-1 level [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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 Name: Biomarker Test
|Contact: Marie Wesselhoftfirstname.lastname@example.org|
|Contact: Ramesh Nayak, PhDemail@example.com|
|United States, Arizona|
|Northwest NeuroSpecialists, PLLC||Recruiting|
|Tucson, Arizona, United States, 85741|
|Contact: Jeanette Wendt, MD 520-742-7890|
|Principal Investigator: Jeanette Wendt, MD|
|Principal Investigator:||Jeannette Wendt, MD||Northwest NeuroSpecialists, PLLC|