A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Information source: MSDx, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing Remitting Multiple Sclerosis
Intervention: MSDX Complex-1 Biomarker test (Other)
Phase: N/A
Status: Recruiting
Sponsored by: MSDx, Inc. Official(s) and/or principal investigator(s): Jeannette Wendt, MD, Principal Investigator, Affiliation: Northwest NeuroSpecialists, PLLC
Overall contact: Marie Wesselhoft, Email: mwesselhoft@msdx.co
Summary
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients
before and after beginning Natalizumab.
Clinical Details
Official title: A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change in MSDX Complex-1 between baseline and 6-month visit
Secondary outcome: Gadolinium MRI and MSDX Complex-1 level
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Marie Wesselhoft, Email: mwesselhoft@msdx.co
Northwest NeuroSpecialists, PLLC, Tucson, Arizona 85741, United States; Recruiting Jeanette Wendt, MD, Phone: 520-742-7890 Jeanette Wendt, MD, Principal Investigator
Additional Information
Starting date: January 2012
Last updated: February 29, 2012
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