A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by MSDx, Inc..
Recruitment status was  Recruiting
Sponsor:
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
  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:


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:

  1. Age 45 years or older of either gender and of any racial/ethnic group.
  2. Subjects must be in generally good health.
  3. Subjects must be able and willing to comply with the requirements of the protocol.
  4. Must be diagnosed with RRMS
  5. Meets the criteria to enter Group 1 or Group 2

Exclusion Criteria:

  1. Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
  2. 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 April 17, 2014