A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Completed
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Registration Number
- NCT01541618
- Lead Sponsor
- MSDx, Inc.
- Brief Summary
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in MSDX Complex-1 between baseline and 6-month visit 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 Outcome Measures
Name Time Method Gadolinium MRI and MSDX Complex-1 level 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.
Trial Locations
- Locations (1)
Northwest NeuroSpecialists, PLLC
🇺🇸Tucson, Arizona, United States
Northwest NeuroSpecialists, PLLC🇺🇸Tucson, Arizona, United States