A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Recruitment status was Recruiting
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541618
|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|