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A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

This study is currently recruiting participants.
Verified February 2012 by MSDx, Inc.
Sponsor:
Information provided by (Responsible Party):
MSDx, Inc.
ClinicalTrials.gov Identifier:
NCT01541618
First received: February 21, 2012
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.


Condition Intervention
Relapsing Remitting Multiple Sclerosis
 Other: MSDX Complex-1 Biomarker test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MSDx, Inc.:

Primary Outcome Measures:
  • Change in MSDX Complex-1 between baseline and 6-month visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Gadolinium MRI and MSDX Complex-1 level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
 Other: MSDX Complex-1 Biomarker test
MSDX Complex-1 Biomarker test
Other Name: Biomarker Test

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541618

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: Jeanette Wendt, MD     520-742-7890        
Principal Investigator: Jeanette Wendt, MD            
Sponsors and Collaborators
MSDx, Inc.
Investigators
Principal Investigator: Jeannette Wendt, MD Northwest NeuroSpecialists, PLLC
  More Information

No publications provided

Responsible Party: MSDx, Inc.
ClinicalTrials.gov Identifier: NCT01541618     History of Changes
Other Study ID Numbers: MSDX-0411
Study First Received: February 21, 2012
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MSDx, Inc.:
MS
RRMS
RR Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 21, 2013