A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
1 other identifier
observational
15
1 country
1
Brief Summary
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedSeptember 2, 2020
February 1, 2012
6 months
February 21, 2012
August 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Gadolinium MRI and MSDX Complex-1 level
6 months
Study Arms (1)
Tysabri Group
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).
Interventions
MSDX Complex-1 Biomarker test
Eligibility Criteria
The study populations for this study is a patient 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).
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MSDx, Inc.lead
Study Sites (1)
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741, United States
Biospecimen
Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeannette Wendt, MD
Northwest NeuroSpecialists, PLLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
March 1, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
September 2, 2020
Record last verified: 2012-02