A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis
This study is currently recruiting participants.
Verified February 2012 by MSDx, Inc.
Sponsor:
MSDx, Inc.
Information provided by (Responsible Party):
MSDx, Inc.
ClinicalTrials.gov Identifier:
NCT01539395
First received: February 21, 2012
Last updated: February 24, 2012
Last verified: February 2012
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Purpose
This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Other: MSDx Complex-1 Biomarker Test |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by MSDx, Inc.:
Primary Outcome Measures:
- Biomarker Differential [ Time Frame: Baseline ] [ Designated as safety issue: No ]A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse
Secondary Outcome Measures:
- Biomarker reduction with steroid therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]A decrease in the level of MSDx Complex-1 in response to steroid therapy for a relapse of MS.
Biospecimen Retention: Samples With DNA
Blood remaining after testing for MSDx Complex-1 will be retained for evaluation for other MS biomarkers
| Estimated Enrollment: | 65 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Inactive Disease
Inactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri.
|
Other: MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1
|
|
Active Disease
Active disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months.
|
Other: MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1
|
|
Active Disease - Steroid Therapy
Patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).
|
Other: MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1
|
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who currently diagnosed with relapsing remitting multiple sclerosis
Criteria
Inclusion Criteria:
- Age 45 years or older of either gender and of any racial/ethnic group.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- Must be diagnosed with RRMS
- Meets the criteria to enter Group 1 or Group 2
Exclusion Criteria:
- Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
- Subject currently has a condition such as active influenza that would stimulate the immune system
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539395
Contacts
| Contact: Marie Wesselhoft | mwesselhoft@msdx.co | |
| Contact: Ramesh Nayak, PhD | rnayak@msdx.co |
Locations
| United States, Arizona | |
| Northwest NeuroSpecialists, PLLC | Recruiting |
| Tucson, Arizona, United States, 85741 | |
| Contact: Jeannette Wendt 520-742-7890 | |
| Principal Investigator: Jeannette Wendt, MD | |
Sponsors and Collaborators
MSDx, Inc.
Investigators
| Principal Investigator: | Jeanette K Wendt, MD | Northwest NeuroSpecialists, PLLC |
More Information
No publications provided
| Responsible Party: | MSDx, Inc. |
| ClinicalTrials.gov Identifier: | NCT01539395 History of Changes |
| Other Study ID Numbers: | MSDX0211 |
| Study First Received: | February 21, 2012 |
| Last Updated: | February 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by MSDx, Inc.:
|
Relapsing Remitting MS |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013